Trial Outcomes & Findings for A Study to Test Combination Treatments in Participants With Advanced Gastric Cancer (NCT NCT02935634)
NCT ID: NCT02935634
Last Updated: 2023-06-09
Results Overview
ORR is the percent of participants whose best overall response (BOR) is complete response (CR) or partial response (PR). BOR is the best response from the start of the study treatment until objectively documented progression per RECIST v1.1 or subsequent anticancer therapy, whichever occurs first. CR is the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) have reduction in short axis to \<10 mm. PR is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. The Response Evaluation Criteria in Solid Tumors (RECIST) is a standard way to measure the response of a tumor to treatment. CR+PR, confidence interval based on Clopper and Pearson method.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
190 participants
Primary outcome timeframe
From first dose of study treatment until progression or subsequent anticancer therapy, whichever occurs first (up to approximately 65 months)
Results posted on
2023-06-09
Participant Flow
Of the 190 participants that were randomized, 104 were initially randomized to Track 1 and 86 were initially randomized to Track 2. The 93 participants that started treatment in Track 2 include the total number of participants that received treatment in each arm which incorporates the 20 participants from Track 1 or 2 that were re-randomized to receive a different treatment combination in Track 2.
Participant milestones
| Measure |
Nivolumab + Ipilimumab
Participants received nivolumab 1 mg/kg via IV infusion followed by ipilimumab 3 mg/kg administered IV Q3W, followed 6 weeks after the last dose of combination study treatment by nivolumab 480 mg administered IV Q4W for 2 years.
|
Nivolumab + BMS-986016
Participants received nivolumab 240 mg via IV infusion Q2W followed by BMS-986016 80 mg administered IV Q2W for 2 years.
|
Nivolumab + BMS-986205
Participants received nivolumab 480 mg Q4W and BMS-986205 100 mg QD for 104 weeks.
|
Nivolumab + Rucaparib
Participants received nivolumab 480 mg administered IV Q4W in combination with rucaparib 600 mg administered orally twice daily for 2 years.
|
Ipilimumab + Rucaparib
Participants received ipilimumab 3 mg/kg administered IV Q4W in combination with rucaparib 600 mg orally twice daily for 2 years.
|
Nivolumab + Ipilimumab + Rucaparib
Participants received nivolumab 480 mg administered IV Q4W in combination with ipilimumab 1 mg/kg administered IV Q6W and rucaparib 600 mg orally twice daily for 2 years.
|
|---|---|---|---|---|---|---|
|
Randomization
STARTED
|
42
|
54
|
62
|
12
|
10
|
10
|
|
Randomization
Randomized to Track 1
|
23
|
22
|
38
|
7
|
8
|
6
|
|
Randomization
Randomized to Track 2
|
19
|
32
|
24
|
5
|
2
|
4
|
|
Randomization
COMPLETED
|
40
|
50
|
59
|
12
|
10
|
10
|
|
Randomization
NOT COMPLETED
|
2
|
4
|
3
|
0
|
0
|
0
|
|
Treatment: Track 1
STARTED
|
23
|
20
|
38
|
7
|
8
|
6
|
|
Treatment: Track 1
Re-Randomized to Track 2
|
2
|
3
|
3
|
0
|
0
|
0
|
|
Treatment: Track 1
COMPLETED
|
1
|
1
|
1
|
0
|
0
|
0
|
|
Treatment: Track 1
NOT COMPLETED
|
22
|
19
|
37
|
7
|
8
|
6
|
|
Treatment: Track 2
STARTED
|
23
|
36
|
22
|
6
|
2
|
4
|
|
Treatment: Track 2
No Pre-Randomization
|
17
|
30
|
21
|
5
|
2
|
4
|
|
Treatment: Track 2
Re-Randomized From Track 1 Nivolumab + Relatlimab
|
1
|
0
|
1
|
1
|
0
|
0
|
|
Treatment: Track 2
Re-Randomized From Track 1 Nivolumab + Ipilimumab
|
2
|
1
|
0
|
0
|
0
|
0
|
|
Treatment: Track 2
Re-Randomized From Track 2 Nivolumab + Relatlimab
|
0
|
2
|
0
|
0
|
0
|
0
|
|
Treatment: Track 2
Re-Randomized From Track 2 Nivolumab + BMS986205
|
3
|
0
|
0
|
0
|
0
|
0
|
|
Treatment: Track 2
Previously Un-Treated But Re-Randomized
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Treatment: Track 2
Re-Randomized From Track 2 Nivolumab + Ipilimumab
|
0
|
2
|
0
|
0
|
0
|
0
|
|
Treatment: Track 2
COMPLETED
|
1
|
2
|
0
|
1
|
0
|
0
|
|
Treatment: Track 2
NOT COMPLETED
|
22
|
34
|
22
|
5
|
2
|
4
|
Reasons for withdrawal
| Measure |
Nivolumab + Ipilimumab
Participants received nivolumab 1 mg/kg via IV infusion followed by ipilimumab 3 mg/kg administered IV Q3W, followed 6 weeks after the last dose of combination study treatment by nivolumab 480 mg administered IV Q4W for 2 years.
|
Nivolumab + BMS-986016
Participants received nivolumab 240 mg via IV infusion Q2W followed by BMS-986016 80 mg administered IV Q2W for 2 years.
|
Nivolumab + BMS-986205
Participants received nivolumab 480 mg Q4W and BMS-986205 100 mg QD for 104 weeks.
|
Nivolumab + Rucaparib
Participants received nivolumab 480 mg administered IV Q4W in combination with rucaparib 600 mg administered orally twice daily for 2 years.
|
Ipilimumab + Rucaparib
Participants received ipilimumab 3 mg/kg administered IV Q4W in combination with rucaparib 600 mg orally twice daily for 2 years.
|
Nivolumab + Ipilimumab + Rucaparib
Participants received nivolumab 480 mg administered IV Q4W in combination with ipilimumab 1 mg/kg administered IV Q6W and rucaparib 600 mg orally twice daily for 2 years.
|
|---|---|---|---|---|---|---|
|
Randomization
Participant withdrew consent
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Randomization
Death
|
2
|
1
|
1
|
0
|
0
|
0
|
|
Randomization
Other reasons
|
0
|
2
|
2
|
0
|
0
|
0
|
|
Treatment: Track 1
Disease progression
|
15
|
17
|
28
|
4
|
6
|
2
|
|
Treatment: Track 1
Adverse event unrelated to study drug
|
1
|
1
|
2
|
3
|
0
|
3
|
|
Treatment: Track 1
Lost to Follow-up
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Treatment: Track 1
Study drug toxicity
|
2
|
1
|
3
|
0
|
0
|
1
|
|
Treatment: Track 1
Participant request to discontinue treatment
|
1
|
0
|
1
|
0
|
1
|
0
|
|
Treatment: Track 1
Participant withdrew consent
|
2
|
0
|
1
|
0
|
1
|
0
|
|
Treatment: Track 1
Other reasons
|
0
|
0
|
2
|
0
|
0
|
0
|
|
Treatment: Track 2
Disease progression
|
13
|
26
|
20
|
5
|
1
|
4
|
|
Treatment: Track 2
Adverse event unrelated to study drug
|
2
|
2
|
0
|
0
|
0
|
0
|
|
Treatment: Track 2
Study drug toxicity
|
7
|
3
|
0
|
0
|
0
|
0
|
|
Treatment: Track 2
Participant request to discontinue treatment
|
0
|
2
|
1
|
0
|
0
|
0
|
|
Treatment: Track 2
Participant withdrew consent
|
0
|
1
|
1
|
0
|
1
|
0
|
Baseline Characteristics
A Study to Test Combination Treatments in Participants With Advanced Gastric Cancer
Baseline characteristics by cohort
| Measure |
Track 1: Nivolumab + Ipilimumab
n=23 Participants
Treatment naive participants received nivolumab 1 mg/kg via IV infusion followed by ipilimumab 3 mg/kg administered IV Q3W, followed 6 weeks after the last dose of combination study treatment by nivolumab 480 mg administered IV Q4W for 2 years.
|
Track 1: Nivolumab + BMS-986016
n=22 Participants
Treatment naive participants received nivolumab 240 mg via IV infusion Q2W followed by BMS-986016 80 mg administered IV Q2W for 2 years.
|
Track 1: Nivolumab + BMS-986205
n=38 Participants
Treatment naive participants received nivolumab 480 mg Q4W and BMS-986205 100 mg QD for 104 weeks.
|
Track 1: Nivolumab + Rucaparib
n=7 Participants
Treatment naive participants received nivolumab 480 mg administered IV Q4W in combination with rucaparib 600 mg administered orally twice daily for 2 years.
|
Track 1: Ipilimumab + Rucaparib
n=8 Participants
Treatment naive participants received ipilimumab 3 mg/kg administered IV Q4W in combination with rucaparib 600 mg orally twice daily for 2 years.
|
Track 1: Nivolumab + Ipilimumab + Rucaparib
n=6 Participants
Treatment naive participants received nivolumab 480 mg administered IV Q4W in combination with ipilimumab 1 mg/kg administered IV Q6W and rucaparib 600 mg orally twice daily for 2 years.
|
Track 2: Nivolumab + Ipilimumab
n=19 Participants
Treatment experienced participants received nivolumab 1 mg/kg via IV infusion followed by ipilimumab 3 mg/kg administered IV Q3W, followed 6 weeks after the last dose of combination study treatment by nivolumab 480 mg administered IV Q4W for 2 years.
|
Track 2: Nivolumab + BMS-986016
n=32 Participants
Treatment experienced participants received nivolumab 240 mg via IV infusion Q2W followed by BMS-986016 80 mg administered IV Q2W for 2 years.
|
Track 2: Nivolumab + BMS-986205
n=24 Participants
Treatment experienced participants received nivolumab 480 mg Q4W and BMS-986205 100 mg QD for 104 weeks.
|
Track 2: Nivolumab + Rucaparib
n=5 Participants
Treatment experienced participants received nivolumab 480 mg administered IV Q4W in combination with rucaparib 600 mg administered orally twice daily for 2 years.
|
Track 2: Ipilimumab + Rucaparib
n=2 Participants
Treatment experienced participants received ipilimumab 3 mg/kg administered IV Q4W in combination with rucaparib 600 mg orally twice daily for 2 years.
|
Track 2: Nivolumab + Ipilimumab + Rucaparib
n=4 Participants
Treatment experienced participants received nivolumab 480 mg administered IV Q4W in combination with ipilimumab 1 mg/kg administered IV Q6W and rucaparib 600 mg orally twice daily for 2 years.
|
Total
n=190 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
62.0 Years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
58.1 Years
STANDARD_DEVIATION 12.6 • n=7 Participants
|
60.6 Years
STANDARD_DEVIATION 12.9 • n=5 Participants
|
58.1 Years
STANDARD_DEVIATION 10.4 • n=4 Participants
|
57.4 Years
STANDARD_DEVIATION 13.9 • n=21 Participants
|
59.5 Years
STANDARD_DEVIATION 6.7 • n=10 Participants
|
55.9 Years
STANDARD_DEVIATION 12.0 • n=115 Participants
|
61.8 Years
STANDARD_DEVIATION 11.8 • n=6 Participants
|
64.2 Years
STANDARD_DEVIATION 9.2 • n=6 Participants
|
58.0 Years
STANDARD_DEVIATION 16.2 • n=64 Participants
|
57.0 Years
STANDARD_DEVIATION 2.8 • n=17 Participants
|
53.0 Years
STANDARD_DEVIATION 16.4 • n=21 Participants
|
60.1 Years
STANDARD_DEVIATION 11.8 • n=22 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
7 Participants
n=6 Participants
|
9 Participants
n=6 Participants
|
1 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
48 Participants
n=22 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
17 Participants
n=115 Participants
|
25 Participants
n=6 Participants
|
15 Participants
n=6 Participants
|
4 Participants
n=64 Participants
|
2 Participants
n=17 Participants
|
4 Participants
n=21 Participants
|
142 Participants
n=22 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
4 Participants
n=22 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
14 Participants
n=115 Participants
|
25 Participants
n=6 Participants
|
17 Participants
n=6 Participants
|
3 Participants
n=64 Participants
|
2 Participants
n=17 Participants
|
2 Participants
n=21 Participants
|
118 Participants
n=22 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
7 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
2 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
2 Participants
n=21 Participants
|
68 Participants
n=22 Participants
|
|
Race/Ethnicity, Customized
White
|
22 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
13 Participants
n=115 Participants
|
29 Participants
n=6 Participants
|
19 Participants
n=6 Participants
|
4 Participants
n=64 Participants
|
1 Participants
n=17 Participants
|
3 Participants
n=21 Participants
|
162 Participants
n=22 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
2 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
1 Participants
n=17 Participants
|
1 Participants
n=21 Participants
|
9 Participants
n=22 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
9 Participants
n=22 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=22 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=22 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
6 Participants
n=22 Participants
|
|
Race/Ethnicity, Customized
Not reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=22 Participants
|
PRIMARY outcome
Timeframe: From first dose of study treatment until progression or subsequent anticancer therapy, whichever occurs first (up to approximately 65 months)Population: All treated participants
ORR is the percent of participants whose best overall response (BOR) is complete response (CR) or partial response (PR). BOR is the best response from the start of the study treatment until objectively documented progression per RECIST v1.1 or subsequent anticancer therapy, whichever occurs first. CR is the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) have reduction in short axis to \<10 mm. PR is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. The Response Evaluation Criteria in Solid Tumors (RECIST) is a standard way to measure the response of a tumor to treatment. CR+PR, confidence interval based on Clopper and Pearson method.
Outcome measures
| Measure |
Track 1: Nivolumab + Ipilimumab
n=23 Participants
Treatment naive participants received nivolumab 1 mg/kg via IV infusion followed by ipilimumab 3 mg/kg administered IV Q3W, followed 6 weeks after the last dose of combination study treatment by nivolumab 480 mg administered IV Q4W for 2 years.
|
Track 1: Nivolumab + BMS-986016
n=20 Participants
Treatment naive participants received nivolumab 240 mg via IV infusion Q2W followed by BMS-986016 80 mg administered IV Q2W for 2 years.
|
Track 1: Nivolumab + BMS-986205
n=38 Participants
Treatment naive participants received nivolumab 480 mg Q4W and BMS-986205 100 mg QD for 104 weeks.
|
Track 1: Nivolumab + Rucaparib
n=7 Participants
Treatment naive participants received nivolumab 480 mg administered IV Q4W in combination with rucaparib 600 mg administered orally twice daily for 2 years.
|
Track 1: Ipilimumab + Rucaparib
n=8 Participants
Treatment naive participants received ipilimumab 3 mg/kg administered IV Q4W in combination with rucaparib 600 mg orally twice daily for 2 years.
|
Track 1: Nivolumab + Ipilimumab + Rucaparib
n=6 Participants
Treatment naive participants received nivolumab 480 mg administered IV Q4W in combination with ipilimumab 1 mg/kg administered IV Q6W and rucaparib 600 mg orally twice daily for 2 years.
|
Track 2: Nivolumab + Ipilimumab
n=23 Participants
Treatment experienced participants received nivolumab 1 mg/kg via IV infusion followed by ipilimumab 3 mg/kg administered IV Q3W, followed 6 weeks after the last dose of combination study treatment by nivolumab 480 mg administered IV Q4W for 2 years.
|
Track 2: Nivolumab + BMS-986016
n=36 Participants
Treatment experienced participants received nivolumab 240 mg via IV infusion Q2W followed by BMS-986016 80 mg administered IV Q2W for 2 years.
|
Track 2: Nivolumab + BMS-986205
n=22 Participants
Treatment experienced participants received nivolumab 480 mg Q4W and BMS-986205 100 mg QD for 104 weeks.
|
Track 2: Nivolumab + Rucaparib
n=6 Participants
Treatment experienced participants received nivolumab 480 mg administered IV Q4W in combination with rucaparib 600 mg administered orally twice daily for 2 years.
|
Track 2: Ipilimumab + Rucaparib
n=2 Participants
Treatment experienced participants received ipilimumab 3 mg/kg administered IV Q4W in combination with rucaparib 600 mg orally twice daily for 2 years.
|
Track 2: Nivolumab + Ipilimumab + Rucaparib
n=4 Participants
Treatment experienced participants received nivolumab 480 mg administered IV Q4W in combination with ipilimumab 1 mg/kg administered IV Q6W and rucaparib 600 mg orally twice daily for 2 years.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Objective Response Rate (ORR) by Investigator
|
4.3 Percent of participants
Interval 0.1 to 21.9
|
5.0 Percent of participants
Interval 0.1 to 24.9
|
13.2 Percent of participants
Interval 4.4 to 28.1
|
0 Percent of participants
Interval 0.0 to 41.0
|
0 Percent of participants
Interval 0.0 to 36.9
|
16.7 Percent of participants
Interval 0.4 to 64.1
|
8.7 Percent of participants
Interval 1.1 to 28.0
|
5.6 Percent of participants
Interval 0.7 to 18.7
|
0 Percent of participants
Interval 0.0 to 15.4
|
0 Percent of participants
Interval 0.0 to 45.9
|
0 Percent of participants
Interval 0.0 to 84.2
|
0 Percent of participants
Interval 0.0 to 60.2
|
PRIMARY outcome
Timeframe: From first dose to date of first documented tumor progression or death due to any cause, whichever occurred first (up to approximately 65 months)Population: All treated participants with a complete response (CR) or partial response (PR)
Duration of Response (DOR) is the time between the date of first response and the date of first documented disease progression as determined by RECIST 1.1 or death due to any cause, whichever occurred first. Complete Response (CR) is the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR) is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Median computed using Kaplan -Meier method.
Outcome measures
| Measure |
Track 1: Nivolumab + Ipilimumab
n=1 Participants
Treatment naive participants received nivolumab 1 mg/kg via IV infusion followed by ipilimumab 3 mg/kg administered IV Q3W, followed 6 weeks after the last dose of combination study treatment by nivolumab 480 mg administered IV Q4W for 2 years.
|
Track 1: Nivolumab + BMS-986016
n=1 Participants
Treatment naive participants received nivolumab 240 mg via IV infusion Q2W followed by BMS-986016 80 mg administered IV Q2W for 2 years.
|
Track 1: Nivolumab + BMS-986205
n=5 Participants
Treatment naive participants received nivolumab 480 mg Q4W and BMS-986205 100 mg QD for 104 weeks.
|
Track 1: Nivolumab + Rucaparib
Treatment naive participants received nivolumab 480 mg administered IV Q4W in combination with rucaparib 600 mg administered orally twice daily for 2 years.
|
Track 1: Ipilimumab + Rucaparib
Treatment naive participants received ipilimumab 3 mg/kg administered IV Q4W in combination with rucaparib 600 mg orally twice daily for 2 years.
|
Track 1: Nivolumab + Ipilimumab + Rucaparib
n=1 Participants
Treatment naive participants received nivolumab 480 mg administered IV Q4W in combination with ipilimumab 1 mg/kg administered IV Q6W and rucaparib 600 mg orally twice daily for 2 years.
|
Track 2: Nivolumab + Ipilimumab
n=2 Participants
Treatment experienced participants received nivolumab 1 mg/kg via IV infusion followed by ipilimumab 3 mg/kg administered IV Q3W, followed 6 weeks after the last dose of combination study treatment by nivolumab 480 mg administered IV Q4W for 2 years.
|
Track 2: Nivolumab + BMS-986016
n=2 Participants
Treatment experienced participants received nivolumab 240 mg via IV infusion Q2W followed by BMS-986016 80 mg administered IV Q2W for 2 years.
|
Track 2: Nivolumab + BMS-986205
Treatment experienced participants received nivolumab 480 mg Q4W and BMS-986205 100 mg QD for 104 weeks.
|
Track 2: Nivolumab + Rucaparib
Treatment experienced participants received nivolumab 480 mg administered IV Q4W in combination with rucaparib 600 mg administered orally twice daily for 2 years.
|
Track 2: Ipilimumab + Rucaparib
Treatment experienced participants received ipilimumab 3 mg/kg administered IV Q4W in combination with rucaparib 600 mg orally twice daily for 2 years.
|
Track 2: Nivolumab + Ipilimumab + Rucaparib
Treatment experienced participants received nivolumab 480 mg administered IV Q4W in combination with ipilimumab 1 mg/kg administered IV Q6W and rucaparib 600 mg orally twice daily for 2 years.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Median Duration of Response (DOR)
|
156.0 Weeks
Interval 156.0 to 156.0
|
NA Weeks
Interval 113.4 to 113.4
Unable to calculate DOR due to insufficient number of participants who responded
|
NA Weeks
Interval 37.3 to 144.0
Unable to calculate DOR due to insufficient number of participants who responded
|
—
|
—
|
NA Weeks
Interval 0.1 to 0.1
Unable to calculate DOR due to insufficient number of participants who responded
|
14.71 Weeks
Interval 0.1 to 14.71
|
16.86 Weeks
Interval 8.1 to 25.6
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 24 weeks after first dosePopulation: All treated participants
The PFSR at 24 weeks is defined as the proportion of treated participants remaining progression free and surviving at 24 weeks since the first dosing date. Progressive Disease (PD) is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Point estimates are derived from Kaplan-Meier analyses, the 95% CIs are derived from Greenwood formula.
Outcome measures
| Measure |
Track 1: Nivolumab + Ipilimumab
n=23 Participants
Treatment naive participants received nivolumab 1 mg/kg via IV infusion followed by ipilimumab 3 mg/kg administered IV Q3W, followed 6 weeks after the last dose of combination study treatment by nivolumab 480 mg administered IV Q4W for 2 years.
|
Track 1: Nivolumab + BMS-986016
n=20 Participants
Treatment naive participants received nivolumab 240 mg via IV infusion Q2W followed by BMS-986016 80 mg administered IV Q2W for 2 years.
|
Track 1: Nivolumab + BMS-986205
n=38 Participants
Treatment naive participants received nivolumab 480 mg Q4W and BMS-986205 100 mg QD for 104 weeks.
|
Track 1: Nivolumab + Rucaparib
n=7 Participants
Treatment naive participants received nivolumab 480 mg administered IV Q4W in combination with rucaparib 600 mg administered orally twice daily for 2 years.
|
Track 1: Ipilimumab + Rucaparib
n=8 Participants
Treatment naive participants received ipilimumab 3 mg/kg administered IV Q4W in combination with rucaparib 600 mg orally twice daily for 2 years.
|
Track 1: Nivolumab + Ipilimumab + Rucaparib
n=6 Participants
Treatment naive participants received nivolumab 480 mg administered IV Q4W in combination with ipilimumab 1 mg/kg administered IV Q6W and rucaparib 600 mg orally twice daily for 2 years.
|
Track 2: Nivolumab + Ipilimumab
n=23 Participants
Treatment experienced participants received nivolumab 1 mg/kg via IV infusion followed by ipilimumab 3 mg/kg administered IV Q3W, followed 6 weeks after the last dose of combination study treatment by nivolumab 480 mg administered IV Q4W for 2 years.
|
Track 2: Nivolumab + BMS-986016
n=36 Participants
Treatment experienced participants received nivolumab 240 mg via IV infusion Q2W followed by BMS-986016 80 mg administered IV Q2W for 2 years.
|
Track 2: Nivolumab + BMS-986205
n=22 Participants
Treatment experienced participants received nivolumab 480 mg Q4W and BMS-986205 100 mg QD for 104 weeks.
|
Track 2: Nivolumab + Rucaparib
n=6 Participants
Treatment experienced participants received nivolumab 480 mg administered IV Q4W in combination with rucaparib 600 mg administered orally twice daily for 2 years.
|
Track 2: Ipilimumab + Rucaparib
n=2 Participants
Treatment experienced participants received ipilimumab 3 mg/kg administered IV Q4W in combination with rucaparib 600 mg orally twice daily for 2 years.
|
Track 2: Nivolumab + Ipilimumab + Rucaparib
n=4 Participants
Treatment experienced participants received nivolumab 480 mg administered IV Q4W in combination with ipilimumab 1 mg/kg administered IV Q6W and rucaparib 600 mg orally twice daily for 2 years.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Kaplan-Meier Analysis of Progression Free Survival Rate (PFSR) at 24 Weeks
|
NA Proportion of participants
Insufficient number of participants with events
|
NA Proportion of participants
Insufficient number of participants with events
|
0.240 Proportion of participants
Interval 0.114 to 0.393
|
NA Proportion of participants
Insufficient number of participants with events
|
NA Proportion of participants
Insufficient number of participants with events
|
NA Proportion of participants
Insufficient number of participants with events
|
NA Proportion of participants
Insufficient number of participants with events
|
0.170 Proportion of participants
Interval 0.063 to 0.322
|
NA Proportion of participants
Insufficient number of participants with events
|
NA Proportion of participants
Insufficient number of participants with events
|
NA Proportion of participants
Insufficient number of participants with events
|
NA Proportion of participants
Insufficient number of participants with events
|
SECONDARY outcome
Timeframe: From first dose to 100 days after last dose of study therapy (assessed up to approximately 30 months)Population: All treated participants
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe), requires inpatient hospitalization or causes prolongation of existing hospitalization.
Outcome measures
| Measure |
Track 1: Nivolumab + Ipilimumab
n=23 Participants
Treatment naive participants received nivolumab 1 mg/kg via IV infusion followed by ipilimumab 3 mg/kg administered IV Q3W, followed 6 weeks after the last dose of combination study treatment by nivolumab 480 mg administered IV Q4W for 2 years.
|
Track 1: Nivolumab + BMS-986016
n=20 Participants
Treatment naive participants received nivolumab 240 mg via IV infusion Q2W followed by BMS-986016 80 mg administered IV Q2W for 2 years.
|
Track 1: Nivolumab + BMS-986205
n=38 Participants
Treatment naive participants received nivolumab 480 mg Q4W and BMS-986205 100 mg QD for 104 weeks.
|
Track 1: Nivolumab + Rucaparib
n=7 Participants
Treatment naive participants received nivolumab 480 mg administered IV Q4W in combination with rucaparib 600 mg administered orally twice daily for 2 years.
|
Track 1: Ipilimumab + Rucaparib
n=8 Participants
Treatment naive participants received ipilimumab 3 mg/kg administered IV Q4W in combination with rucaparib 600 mg orally twice daily for 2 years.
|
Track 1: Nivolumab + Ipilimumab + Rucaparib
n=6 Participants
Treatment naive participants received nivolumab 480 mg administered IV Q4W in combination with ipilimumab 1 mg/kg administered IV Q6W and rucaparib 600 mg orally twice daily for 2 years.
|
Track 2: Nivolumab + Ipilimumab
n=23 Participants
Treatment experienced participants received nivolumab 1 mg/kg via IV infusion followed by ipilimumab 3 mg/kg administered IV Q3W, followed 6 weeks after the last dose of combination study treatment by nivolumab 480 mg administered IV Q4W for 2 years.
|
Track 2: Nivolumab + BMS-986016
n=36 Participants
Treatment experienced participants received nivolumab 240 mg via IV infusion Q2W followed by BMS-986016 80 mg administered IV Q2W for 2 years.
|
Track 2: Nivolumab + BMS-986205
n=22 Participants
Treatment experienced participants received nivolumab 480 mg Q4W and BMS-986205 100 mg QD for 104 weeks.
|
Track 2: Nivolumab + Rucaparib
n=6 Participants
Treatment experienced participants received nivolumab 480 mg administered IV Q4W in combination with rucaparib 600 mg administered orally twice daily for 2 years.
|
Track 2: Ipilimumab + Rucaparib
n=2 Participants
Treatment experienced participants received ipilimumab 3 mg/kg administered IV Q4W in combination with rucaparib 600 mg orally twice daily for 2 years.
|
Track 2: Nivolumab + Ipilimumab + Rucaparib
n=4 Participants
Treatment experienced participants received nivolumab 480 mg administered IV Q4W in combination with ipilimumab 1 mg/kg administered IV Q6W and rucaparib 600 mg orally twice daily for 2 years.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With AEs, SAEs, AEs Leading to Discontinuation, and Death
Adverse Events (AEs)
|
23 Participants
|
20 Participants
|
38 Participants
|
7 Participants
|
8 Participants
|
6 Participants
|
23 Participants
|
36 Participants
|
22 Participants
|
6 Participants
|
2 Participants
|
4 Participants
|
|
Number of Participants With AEs, SAEs, AEs Leading to Discontinuation, and Death
Serious Adverse Events (SAEs)
|
19 Participants
|
15 Participants
|
24 Participants
|
5 Participants
|
6 Participants
|
4 Participants
|
17 Participants
|
24 Participants
|
12 Participants
|
4 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants With AEs, SAEs, AEs Leading to Discontinuation, and Death
AEs Leading to Discontinuation
|
9 Participants
|
7 Participants
|
11 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
10 Participants
|
8 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With AEs, SAEs, AEs Leading to Discontinuation, and Death
Death
|
19 Participants
|
15 Participants
|
26 Participants
|
7 Participants
|
5 Participants
|
4 Participants
|
19 Participants
|
26 Participants
|
13 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: From first dose to 100 days after last dose of study therapy (approximately 30 months)Population: All treated participants with at least one on-treatment TSH measurement
The number of participants with laboratory abnormalities in specific thyroid tests based on US conventional units. TSH = Thyroid Stimulating Hormone LLN = Lower Limit of Normal ULN = Upper Limit of Normal.
Outcome measures
| Measure |
Track 1: Nivolumab + Ipilimumab
n=18 Participants
Treatment naive participants received nivolumab 1 mg/kg via IV infusion followed by ipilimumab 3 mg/kg administered IV Q3W, followed 6 weeks after the last dose of combination study treatment by nivolumab 480 mg administered IV Q4W for 2 years.
|
Track 1: Nivolumab + BMS-986016
n=16 Participants
Treatment naive participants received nivolumab 240 mg via IV infusion Q2W followed by BMS-986016 80 mg administered IV Q2W for 2 years.
|
Track 1: Nivolumab + BMS-986205
n=26 Participants
Treatment naive participants received nivolumab 480 mg Q4W and BMS-986205 100 mg QD for 104 weeks.
|
Track 1: Nivolumab + Rucaparib
n=6 Participants
Treatment naive participants received nivolumab 480 mg administered IV Q4W in combination with rucaparib 600 mg administered orally twice daily for 2 years.
|
Track 1: Ipilimumab + Rucaparib
n=3 Participants
Treatment naive participants received ipilimumab 3 mg/kg administered IV Q4W in combination with rucaparib 600 mg orally twice daily for 2 years.
|
Track 1: Nivolumab + Ipilimumab + Rucaparib
n=3 Participants
Treatment naive participants received nivolumab 480 mg administered IV Q4W in combination with ipilimumab 1 mg/kg administered IV Q6W and rucaparib 600 mg orally twice daily for 2 years.
|
Track 2: Nivolumab + Ipilimumab
n=22 Participants
Treatment experienced participants received nivolumab 1 mg/kg via IV infusion followed by ipilimumab 3 mg/kg administered IV Q3W, followed 6 weeks after the last dose of combination study treatment by nivolumab 480 mg administered IV Q4W for 2 years.
|
Track 2: Nivolumab + BMS-986016
n=27 Participants
Treatment experienced participants received nivolumab 240 mg via IV infusion Q2W followed by BMS-986016 80 mg administered IV Q2W for 2 years.
|
Track 2: Nivolumab + BMS-986205
n=18 Participants
Treatment experienced participants received nivolumab 480 mg Q4W and BMS-986205 100 mg QD for 104 weeks.
|
Track 2: Nivolumab + Rucaparib
n=5 Participants
Treatment experienced participants received nivolumab 480 mg administered IV Q4W in combination with rucaparib 600 mg administered orally twice daily for 2 years.
|
Track 2: Ipilimumab + Rucaparib
n=1 Participants
Treatment experienced participants received ipilimumab 3 mg/kg administered IV Q4W in combination with rucaparib 600 mg orally twice daily for 2 years.
|
Track 2: Nivolumab + Ipilimumab + Rucaparib
n=3 Participants
Treatment experienced participants received nivolumab 480 mg administered IV Q4W in combination with ipilimumab 1 mg/kg administered IV Q6W and rucaparib 600 mg orally twice daily for 2 years.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
TSH < LLN WITH FT3/FT4 TEST MISSING
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
TSH <LLN WITH ALL OTHER FT3/FT4 TEST VALUES <= ULN
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
TSH >ULN WITH ATLEAST ONE FT3/FT4 TEST VALUE <LLN
|
1 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
5 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
TSH >ULN WITH ALL OTHER FT3/FT4 TEST VALUES >= LLN
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
TSH > ULN WITH FT3/FT4 TEST MISSING
|
2 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
TSH < LLN
|
1 Participants
|
2 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
6 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
TSH <LLN WITH TSH >= LLN AT BASELINE
|
0 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
TSH <LLN WITH ATLEAST ONE FT3/FT4 TEST VALUE > ULN
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
TSH > ULN
|
4 Participants
|
4 Participants
|
6 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
11 Participants
|
5 Participants
|
5 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
TSH > ULN WITH TSH <= ULN AT BASELINE
|
3 Participants
|
3 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
6 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From first dose to 100 days after last dose of study therapy (approximately 30 months)Population: All treated participants with at least one on-treatment AST, ALT and/or bilirubin test measurement
The number of participants with laboratory abnormalities in specific liver tests based on US conventional units. ALT = Alanine Aminotransferase AST = Aspartate Aminotransferase ULN = Upper Limit of Normal
Outcome measures
| Measure |
Track 1: Nivolumab + Ipilimumab
n=19 Participants
Treatment naive participants received nivolumab 1 mg/kg via IV infusion followed by ipilimumab 3 mg/kg administered IV Q3W, followed 6 weeks after the last dose of combination study treatment by nivolumab 480 mg administered IV Q4W for 2 years.
|
Track 1: Nivolumab + BMS-986016
n=20 Participants
Treatment naive participants received nivolumab 240 mg via IV infusion Q2W followed by BMS-986016 80 mg administered IV Q2W for 2 years.
|
Track 1: Nivolumab + BMS-986205
n=33 Participants
Treatment naive participants received nivolumab 480 mg Q4W and BMS-986205 100 mg QD for 104 weeks.
|
Track 1: Nivolumab + Rucaparib
n=6 Participants
Treatment naive participants received nivolumab 480 mg administered IV Q4W in combination with rucaparib 600 mg administered orally twice daily for 2 years.
|
Track 1: Ipilimumab + Rucaparib
n=8 Participants
Treatment naive participants received ipilimumab 3 mg/kg administered IV Q4W in combination with rucaparib 600 mg orally twice daily for 2 years.
|
Track 1: Nivolumab + Ipilimumab + Rucaparib
n=4 Participants
Treatment naive participants received nivolumab 480 mg administered IV Q4W in combination with ipilimumab 1 mg/kg administered IV Q6W and rucaparib 600 mg orally twice daily for 2 years.
|
Track 2: Nivolumab + Ipilimumab
n=22 Participants
Treatment experienced participants received nivolumab 1 mg/kg via IV infusion followed by ipilimumab 3 mg/kg administered IV Q3W, followed 6 weeks after the last dose of combination study treatment by nivolumab 480 mg administered IV Q4W for 2 years.
|
Track 2: Nivolumab + BMS-986016
n=32 Participants
Treatment experienced participants received nivolumab 240 mg via IV infusion Q2W followed by BMS-986016 80 mg administered IV Q2W for 2 years.
|
Track 2: Nivolumab + BMS-986205
n=22 Participants
Treatment experienced participants received nivolumab 480 mg Q4W and BMS-986205 100 mg QD for 104 weeks.
|
Track 2: Nivolumab + Rucaparib
n=6 Participants
Treatment experienced participants received nivolumab 480 mg administered IV Q4W in combination with rucaparib 600 mg administered orally twice daily for 2 years.
|
Track 2: Ipilimumab + Rucaparib
n=2 Participants
Treatment experienced participants received ipilimumab 3 mg/kg administered IV Q4W in combination with rucaparib 600 mg orally twice daily for 2 years.
|
Track 2: Nivolumab + Ipilimumab + Rucaparib
n=3 Participants
Treatment experienced participants received nivolumab 480 mg administered IV Q4W in combination with ipilimumab 1 mg/kg administered IV Q6W and rucaparib 600 mg orally twice daily for 2 years.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Laboratory Abnormalities in Specific Liver Tests
ALT OR AST > 3XULN
|
6 Participants
|
6 Participants
|
5 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
6 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Liver Tests
ALT OR AST> 5XULN
|
3 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Liver Tests
ALT OR AST > 20XULN
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Liver Tests
TOTAL BILIRUBIN > 2XULN
|
2 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Liver Tests
ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 1 DAY
|
2 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Liver Tests
ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 30 DAYS
|
2 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Liver Tests
ALT OR AST> 10XULN
|
2 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
Adverse Events
Track 1: Nivolumab + Ipilimumab
Serious events: 19 serious events
Other events: 21 other events
Deaths: 19 deaths
Track 1: Nivolumab + BMS-986016
Serious events: 15 serious events
Other events: 20 other events
Deaths: 15 deaths
Track 1: Nivolumab + BMS-986205
Serious events: 24 serious events
Other events: 38 other events
Deaths: 26 deaths
Track 1: Nivolumab + Rucaparib
Serious events: 5 serious events
Other events: 7 other events
Deaths: 7 deaths
Track 1: Ipilimumab + Rucaparib
Serious events: 6 serious events
Other events: 8 other events
Deaths: 5 deaths
Track 1: Nivolumab + Ipilimumab + Rucaparib
Serious events: 4 serious events
Other events: 6 other events
Deaths: 4 deaths
Track 2: Nivolumab + Ipilimumab
Serious events: 17 serious events
Other events: 23 other events
Deaths: 19 deaths
Track 2: Nivolumab + BMS-986016
Serious events: 24 serious events
Other events: 34 other events
Deaths: 26 deaths
Track 2: Nivolumab + BMS-986205
Serious events: 12 serious events
Other events: 21 other events
Deaths: 13 deaths
Track 2: Nivolumab + Rucaparib
Serious events: 4 serious events
Other events: 6 other events
Deaths: 3 deaths
Track 2: Ipilimumab + Rucaparib
Serious events: 2 serious events
Other events: 2 other events
Deaths: 2 deaths
Track 2: Nivolumab + Ipilimumab + Rucaparib
Serious events: 3 serious events
Other events: 4 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Track 1: Nivolumab + Ipilimumab
n=23 participants at risk
Treatment naive participants received nivolumab 1 mg/kg via IV infusion followed by ipilimumab 3 mg/kg administered IV Q3W, followed 6 weeks after the last dose of combination study treatment by nivolumab 480 mg administered IV Q4W for 2 years.
|
Track 1: Nivolumab + BMS-986016
n=20 participants at risk
Treatment naive participants received nivolumab 240 mg via IV infusion Q2W followed by BMS-986016 80 mg administered IV Q2W for 2 years.
|
Track 1: Nivolumab + BMS-986205
n=38 participants at risk
Treatment naive participants received nivolumab 480 mg Q4W and BMS-986205 100 mg QD for 104 weeks.
|
Track 1: Nivolumab + Rucaparib
n=7 participants at risk
Treatment naive participants received nivolumab 480 mg administered IV Q4W in combination with rucaparib 600 mg administered orally twice daily for 2 years.
|
Track 1: Ipilimumab + Rucaparib
n=8 participants at risk
Treatment naive participants received ipilimumab 3 mg/kg administered IV Q4W in combination with rucaparib 600 mg orally twice daily for 2 years.
|
Track 1: Nivolumab + Ipilimumab + Rucaparib
n=6 participants at risk
Treatment naive participants received nivolumab 480 mg administered IV Q4W in combination with ipilimumab 1 mg/kg administered IV Q6W and rucaparib 600 mg orally twice daily for 2 years.
|
Track 2: Nivolumab + Ipilimumab
n=23 participants at risk
Treatment experienced participants received nivolumab 1 mg/kg via IV infusion followed by ipilimumab 3 mg/kg administered IV Q3W, followed 6 weeks after the last dose of combination study treatment by nivolumab 480 mg administered IV Q4W for 2 years.
|
Track 2: Nivolumab + BMS-986016
n=36 participants at risk
Treatment experienced participants received nivolumab 240 mg via IV infusion Q2W followed by BMS-986016 80 mg administered IV Q2W for 2 years.
|
Track 2: Nivolumab + BMS-986205
n=22 participants at risk
Treatment experienced participants received nivolumab 480 mg Q4W and BMS-986205 100 mg QD for 104 weeks.
|
Track 2: Nivolumab + Rucaparib
n=6 participants at risk
Treatment experienced participants received nivolumab 480 mg administered IV Q4W in combination with rucaparib 600 mg administered orally twice daily for 2 years.
|
Track 2: Ipilimumab + Rucaparib
n=2 participants at risk
Treatment experienced participants received ipilimumab 3 mg/kg administered IV Q4W in combination with rucaparib 600 mg orally twice daily for 2 years.
|
Track 2: Nivolumab + Ipilimumab + Rucaparib
n=4 participants at risk
Treatment experienced participants received nivolumab 480 mg administered IV Q4W in combination with ipilimumab 1 mg/kg administered IV Q6W and rucaparib 600 mg orally twice daily for 2 years.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
4.3%
1/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
15.0%
3/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
5.3%
2/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
8.7%
2/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
2.8%
1/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
25.0%
1/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
4.3%
1/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
2.8%
1/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
4.3%
1/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
5.0%
1/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
2.6%
1/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
2.8%
1/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Endocrine disorders
Basedow's disease
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
4.3%
1/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Endocrine disorders
Lymphocytic hypophysitis
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
4.3%
1/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Endocrine disorders
Secondary adrenocortical insufficiency
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
2.8%
1/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Abdominal pain
|
4.3%
1/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
2.6%
1/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
13.0%
3/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
8.3%
3/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
4.5%
1/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
5.0%
1/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
2.6%
1/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
8.7%
2/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
5.3%
2/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
13.0%
3/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
4.5%
1/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Duodenal obstruction
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
2.6%
1/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Dysphagia
|
4.3%
1/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
10.0%
2/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
10.5%
4/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
13.0%
3/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
2.8%
1/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Gastric perforation
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
4.3%
1/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
2.6%
1/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
4.3%
1/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Ileus
|
4.3%
1/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
2.6%
1/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
5.0%
1/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
2.8%
1/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Oesophageal perforation
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
5.0%
1/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
4.3%
1/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
2.8%
1/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
2.6%
1/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
10.0%
2/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
General disorders
Asthenia
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
2.8%
1/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
General disorders
Chest discomfort
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
2.6%
1/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
General disorders
Death
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
2.6%
1/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
2.8%
1/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
General disorders
Fatigue
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
5.0%
1/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
General disorders
General physical health deterioration
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
28.6%
2/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
2.8%
1/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
2.6%
1/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
General disorders
Pain
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
5.0%
1/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
General disorders
Performance status decreased
|
4.3%
1/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
General disorders
Pyrexia
|
4.3%
1/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
2.6%
1/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
50.0%
1/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
General disorders
Sudden death
|
4.3%
1/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
General disorders
Systemic inflammatory response syndrome
|
4.3%
1/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
5.0%
1/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
8.7%
2/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
2.8%
1/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Hepatic haematoma
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
2.8%
1/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
50.0%
1/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
5.0%
1/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Infections and infestations
Atypical pneumonia
|
4.3%
1/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
4.3%
1/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Infections and infestations
Ophthalmic herpes zoster
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
2.6%
1/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
4.3%
1/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Infections and infestations
Pneumonia
|
4.3%
1/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
5.3%
2/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
50.0%
1/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Infections and infestations
Pneumonia viral
|
4.3%
1/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Infections and infestations
Sepsis
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
2.6%
1/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
2.8%
1/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Infections and infestations
Skin bacterial infection
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
25.0%
1/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Infections and infestations
Streptococcal bacteraemia
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
2.6%
1/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
2.6%
1/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
2.8%
1/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Infections and infestations
Vascular device infection
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Infections and infestations
Wound infection
|
4.3%
1/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Acetabulum fracture
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
2.6%
1/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
4.3%
1/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
4.3%
1/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
2.6%
1/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
4.3%
1/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
5.0%
1/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
4.3%
1/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
4.5%
1/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
4.3%
1/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
2.6%
1/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
2.8%
1/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
2.6%
1/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Investigations
Weight decreased
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
2.6%
1/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
5.3%
2/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
13.0%
3/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
2.8%
1/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
4.5%
1/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
5.0%
1/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
4.3%
1/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
5.0%
1/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
5.6%
2/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
2.6%
1/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
4.3%
1/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
2.6%
1/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
4.5%
1/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
2.8%
1/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Keratoacanthoma
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
4.5%
1/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
47.8%
11/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
30.0%
6/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
28.9%
11/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
37.5%
3/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
21.7%
5/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
25.0%
9/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
36.4%
8/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
33.3%
2/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
50.0%
1/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
50.0%
2/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
5.0%
1/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
2.8%
1/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
2.8%
1/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour perforation
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
2.6%
1/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
2.6%
1/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
2.8%
1/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
2.8%
1/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
2.8%
1/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Nervous system disorders
Seizure
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
2.8%
1/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Nervous system disorders
Syncope
|
4.3%
1/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Nervous system disorders
Transient ischaemic attack
|
4.3%
1/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Product Issues
Device dislocation
|
4.3%
1/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
2.6%
1/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
25.0%
1/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
2.8%
1/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
13.0%
3/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
25.0%
1/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
5.0%
1/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
5.3%
2/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
4.3%
1/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
9.1%
2/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
25.0%
1/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
4.5%
1/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
2.8%
1/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
13.0%
3/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
5.0%
1/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
2.8%
1/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
4.3%
1/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
2.8%
1/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
2.6%
1/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
2.8%
1/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
2.6%
1/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Vascular disorders
Embolism
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
2.6%
1/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Vascular disorders
Hypotension
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
4.5%
1/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Vascular disorders
Superior vena cava stenosis
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
Other adverse events
| Measure |
Track 1: Nivolumab + Ipilimumab
n=23 participants at risk
Treatment naive participants received nivolumab 1 mg/kg via IV infusion followed by ipilimumab 3 mg/kg administered IV Q3W, followed 6 weeks after the last dose of combination study treatment by nivolumab 480 mg administered IV Q4W for 2 years.
|
Track 1: Nivolumab + BMS-986016
n=20 participants at risk
Treatment naive participants received nivolumab 240 mg via IV infusion Q2W followed by BMS-986016 80 mg administered IV Q2W for 2 years.
|
Track 1: Nivolumab + BMS-986205
n=38 participants at risk
Treatment naive participants received nivolumab 480 mg Q4W and BMS-986205 100 mg QD for 104 weeks.
|
Track 1: Nivolumab + Rucaparib
n=7 participants at risk
Treatment naive participants received nivolumab 480 mg administered IV Q4W in combination with rucaparib 600 mg administered orally twice daily for 2 years.
|
Track 1: Ipilimumab + Rucaparib
n=8 participants at risk
Treatment naive participants received ipilimumab 3 mg/kg administered IV Q4W in combination with rucaparib 600 mg orally twice daily for 2 years.
|
Track 1: Nivolumab + Ipilimumab + Rucaparib
n=6 participants at risk
Treatment naive participants received nivolumab 480 mg administered IV Q4W in combination with ipilimumab 1 mg/kg administered IV Q6W and rucaparib 600 mg orally twice daily for 2 years.
|
Track 2: Nivolumab + Ipilimumab
n=23 participants at risk
Treatment experienced participants received nivolumab 1 mg/kg via IV infusion followed by ipilimumab 3 mg/kg administered IV Q3W, followed 6 weeks after the last dose of combination study treatment by nivolumab 480 mg administered IV Q4W for 2 years.
|
Track 2: Nivolumab + BMS-986016
n=36 participants at risk
Treatment experienced participants received nivolumab 240 mg via IV infusion Q2W followed by BMS-986016 80 mg administered IV Q2W for 2 years.
|
Track 2: Nivolumab + BMS-986205
n=22 participants at risk
Treatment experienced participants received nivolumab 480 mg Q4W and BMS-986205 100 mg QD for 104 weeks.
|
Track 2: Nivolumab + Rucaparib
n=6 participants at risk
Treatment experienced participants received nivolumab 480 mg administered IV Q4W in combination with rucaparib 600 mg administered orally twice daily for 2 years.
|
Track 2: Ipilimumab + Rucaparib
n=2 participants at risk
Treatment experienced participants received ipilimumab 3 mg/kg administered IV Q4W in combination with rucaparib 600 mg orally twice daily for 2 years.
|
Track 2: Nivolumab + Ipilimumab + Rucaparib
n=4 participants at risk
Treatment experienced participants received nivolumab 480 mg administered IV Q4W in combination with ipilimumab 1 mg/kg administered IV Q6W and rucaparib 600 mg orally twice daily for 2 years.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
15.0%
3/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Anaemia
|
26.1%
6/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
40.0%
8/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
31.6%
12/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
37.5%
3/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
33.3%
2/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
30.4%
7/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
30.6%
11/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
31.8%
7/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
25.0%
1/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
4.5%
1/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Neutropenia
|
4.3%
1/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
5.6%
2/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Cardiac disorders
Atrial fibrillation
|
8.7%
2/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
8.7%
2/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
4.3%
1/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
5.6%
2/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
2.6%
1/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
50.0%
1/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
5.6%
2/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
4.5%
1/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Endocrine disorders
Hyperthyroidism
|
4.3%
1/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
8.7%
2/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Endocrine disorders
Hypothyroidism
|
4.3%
1/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
15.0%
3/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
10.5%
4/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
13.0%
3/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
4.5%
1/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Eye disorders
Vision blurred
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
4.3%
1/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
2.8%
1/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Abdominal distension
|
8.7%
2/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
7.9%
3/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
2.8%
1/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
4.5%
1/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Abdominal pain
|
30.4%
7/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
35.0%
7/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
28.9%
11/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
28.6%
2/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
33.3%
2/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
30.4%
7/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
16.7%
6/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
4.5%
1/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
50.0%
3/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
50.0%
2/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.3%
1/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
20.0%
4/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
5.3%
2/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
33.3%
2/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
4.3%
1/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
5.6%
2/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
13.6%
3/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
5.0%
1/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
5.3%
2/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
5.6%
2/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Colitis
|
4.3%
1/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Constipation
|
13.0%
3/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
25.0%
5/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
23.7%
9/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
28.6%
2/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
25.0%
2/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
33.3%
2/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
30.4%
7/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
16.7%
6/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
18.2%
4/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
33.3%
2/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
50.0%
1/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
25.0%
1/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
8.7%
2/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
25.0%
5/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
18.4%
7/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
57.1%
4/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
33.3%
2/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
30.4%
7/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
19.4%
7/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
13.6%
3/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
33.3%
2/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
50.0%
1/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
25.0%
1/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Dry mouth
|
4.3%
1/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
5.0%
1/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
5.3%
2/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
8.7%
2/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
2.8%
1/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
4.5%
1/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
10.0%
2/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
5.3%
2/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
13.0%
3/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
4.5%
1/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Dysphagia
|
26.1%
6/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
15.0%
3/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
21.1%
8/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
42.9%
3/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
33.3%
2/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
17.4%
4/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
13.9%
5/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
4.5%
1/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
25.0%
1/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Flatulence
|
4.3%
1/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
5.0%
1/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
7.9%
3/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
4.3%
1/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
2.8%
1/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
4.5%
1/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
20.0%
4/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
5.3%
2/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
2.8%
1/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
9.1%
2/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
50.0%
1/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Jejunal stenosis
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
2.6%
1/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
50.0%
1/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Nausea
|
34.8%
8/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
50.0%
10/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
44.7%
17/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
57.1%
4/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
50.0%
4/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
33.3%
2/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
43.5%
10/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
25.0%
9/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
27.3%
6/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
66.7%
4/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
50.0%
2/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Oesophageal pain
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
5.0%
1/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
2.6%
1/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
4.5%
1/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
28.6%
2/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
5.0%
1/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
8.7%
2/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
4.5%
1/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Vomiting
|
30.4%
7/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
25.0%
5/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
18.4%
7/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
33.3%
2/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
30.4%
7/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
19.4%
7/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
4.5%
1/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
33.3%
2/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
50.0%
2/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
General disorders
Asthenia
|
17.4%
4/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
15.0%
3/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
10.5%
4/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
25.0%
2/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
4.3%
1/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
General disorders
Chills
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
5.0%
1/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
5.3%
2/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
4.3%
1/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
33.3%
2/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
50.0%
1/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
General disorders
Early satiety
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
5.0%
1/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
5.3%
2/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
4.5%
1/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
General disorders
Fatigue
|
56.5%
13/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
55.0%
11/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
60.5%
23/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
28.6%
2/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
62.5%
5/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
33.3%
2/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
43.5%
10/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
61.1%
22/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
50.0%
11/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
83.3%
5/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
100.0%
2/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
50.0%
2/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
General disorders
General physical health deterioration
|
8.7%
2/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
General disorders
Influenza like illness
|
4.3%
1/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
5.0%
1/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
5.3%
2/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
General disorders
Malaise
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
2.6%
1/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
5.6%
2/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
4.3%
1/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
7.9%
3/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
13.0%
3/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
2.8%
1/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
9.1%
2/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
25.0%
1/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
General disorders
Oedema peripheral
|
13.0%
3/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
5.0%
1/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
7.9%
3/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
4.3%
1/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
13.9%
5/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
18.2%
4/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
25.0%
1/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
General disorders
Pain
|
4.3%
1/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
5.0%
1/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
5.3%
2/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
2.8%
1/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
General disorders
Pyrexia
|
30.4%
7/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
15.0%
3/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
21.1%
8/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
25.0%
2/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
17.4%
4/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
13.9%
5/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
9.1%
2/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
33.3%
2/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
25.0%
1/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
4.3%
1/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
4.3%
1/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Infections and infestations
COVID-19
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
50.0%
1/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Infections and infestations
Genital herpes
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Infections and infestations
Lymph gland infection
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
25.0%
1/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Infections and infestations
Paronychia
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Infections and infestations
Pneumonia
|
4.3%
1/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
5.0%
1/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
4.5%
1/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Infections and infestations
Sepsis
|
4.3%
1/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
5.3%
2/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
5.3%
2/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
4.5%
1/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Contusion
|
4.3%
1/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
5.0%
1/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
2.8%
1/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
5.0%
1/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
2.6%
1/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
8.7%
2/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
2.6%
1/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
5.6%
2/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
5.3%
2/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
5.6%
2/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
9.1%
2/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
25.0%
5/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
18.4%
7/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
37.5%
3/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
66.7%
4/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
21.7%
5/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
8.3%
3/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
9.1%
2/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
50.0%
1/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Investigations
Amylase increased
|
4.3%
1/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
15.0%
3/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
10.5%
4/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
4.3%
1/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
2.8%
1/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
13.6%
3/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
50.0%
1/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
25.0%
5/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
21.1%
8/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
28.6%
2/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
37.5%
3/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
66.7%
4/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
21.7%
5/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
8.3%
3/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
18.2%
4/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
50.0%
1/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
25.0%
1/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Investigations
Blood alkaline phosphatase increased
|
13.0%
3/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
15.0%
3/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
13.2%
5/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
42.9%
3/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
33.3%
2/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
26.1%
6/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
11.1%
4/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
18.2%
4/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Investigations
Blood bilirubin increased
|
8.7%
2/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
30.0%
6/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
7.9%
3/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
28.6%
2/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
8.7%
2/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
5.6%
2/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
13.6%
3/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Investigations
Blood creatine increased
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
25.0%
1/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
10.0%
2/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
5.3%
2/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
2.8%
1/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
5.0%
1/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
7.9%
3/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
13.0%
3/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
2.8%
1/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
4.5%
1/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Investigations
Blood pressure increased
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
8.7%
2/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Investigations
Blood urea increased
|
4.3%
1/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
25.0%
1/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
25.0%
1/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
2.8%
1/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
4.5%
1/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Investigations
Gamma-glutamyltransferase increased
|
17.4%
4/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
10.0%
2/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
5.3%
2/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
28.6%
2/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
4.3%
1/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
2.8%
1/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Investigations
Glomerular filtration rate decreased
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
25.0%
1/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
5.0%
1/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
8.3%
3/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
9.1%
2/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Investigations
Lipase increased
|
8.7%
2/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
15.0%
3/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
7.9%
3/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
8.7%
2/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
2.8%
1/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
18.2%
4/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Investigations
Lymph node palpable
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
5.0%
1/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
2.6%
1/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
16.7%
6/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
13.6%
3/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
50.0%
1/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
5.0%
1/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
2.8%
1/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
4.5%
1/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
50.0%
1/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Investigations
Platelet count decreased
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
10.0%
2/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
5.3%
2/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
5.6%
2/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
13.6%
3/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
50.0%
1/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Investigations
Weight decreased
|
17.4%
4/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
10.0%
2/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
10.5%
4/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
28.6%
2/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
25.0%
2/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
8.7%
2/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
5.6%
2/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
9.1%
2/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
25.0%
1/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
10.0%
2/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
2.6%
1/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
11.1%
4/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
9.1%
2/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
43.5%
10/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
50.0%
10/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
23.7%
9/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
28.6%
2/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
25.0%
2/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
30.4%
7/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
38.9%
14/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
36.4%
8/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
33.3%
2/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
50.0%
1/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
50.0%
2/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
7.9%
3/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
4.3%
1/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
5.6%
2/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
13.6%
3/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
4.3%
1/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
10.0%
2/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
10.5%
4/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
4.3%
1/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
19.4%
7/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
18.2%
4/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
2.6%
1/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
5.6%
2/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
5.6%
2/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
13.0%
3/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
25.0%
5/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
10.5%
4/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
13.0%
3/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
13.9%
5/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
13.6%
3/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
50.0%
1/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
10.0%
2/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
5.3%
2/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
8.7%
2/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
11.1%
4/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
4.5%
1/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
13.0%
3/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
15.0%
3/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
2.6%
1/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
8.7%
2/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
5.6%
2/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
25.0%
1/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
8.7%
2/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
10.0%
2/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
7.9%
3/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
4.3%
1/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
11.1%
4/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
4.5%
1/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
50.0%
1/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
25.0%
1/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
21.7%
5/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
25.0%
5/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
10.5%
4/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
13.0%
3/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
11.1%
4/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
4.5%
1/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
50.0%
1/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
15.0%
3/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
2.6%
1/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
13.0%
3/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
2.8%
1/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
50.0%
1/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
25.0%
1/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
5.6%
2/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.7%
2/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
20.0%
4/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
5.3%
2/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
21.7%
5/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
8.3%
3/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
9.1%
2/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
25.0%
1/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
10.0%
2/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
4.3%
1/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.7%
2/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
25.0%
5/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
7.9%
3/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
13.0%
3/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
8.3%
3/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
13.6%
3/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
50.0%
3/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Chondrocalcinosis pyrophosphate
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
5.3%
2/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
5.6%
2/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
4.5%
1/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
5.3%
2/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
4.3%
1/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
2.8%
1/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
4.5%
1/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
25.0%
1/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
5.0%
1/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
2.8%
1/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
4.5%
1/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
8.7%
2/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
5.0%
1/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
4.3%
1/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.3%
1/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
10.0%
2/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
4.3%
1/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
5.6%
2/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
25.0%
1/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
8.3%
3/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.7%
2/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
10.0%
2/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
10.5%
4/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
8.7%
2/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
4.5%
1/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Sacral pain
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
25.0%
1/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Nervous system disorders
Dizziness
|
8.7%
2/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
5.0%
1/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
13.2%
5/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
21.7%
5/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
25.0%
9/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
18.2%
4/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
20.0%
4/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
4.3%
1/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
2.8%
1/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
4.5%
1/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
50.0%
1/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
25.0%
1/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Nervous system disorders
Headache
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
10.0%
2/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
15.8%
6/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
33.3%
2/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
4.3%
1/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
13.9%
5/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
4.5%
1/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
5.3%
2/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
4.3%
1/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
4.5%
1/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
5.0%
1/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
7.9%
3/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
8.3%
3/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Nervous system disorders
Polyneuropathy
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Nervous system disorders
Restless legs syndrome
|
4.3%
1/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Nervous system disorders
Tremor
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
5.0%
1/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
2.6%
1/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
8.7%
2/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
9.1%
2/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
13.0%
3/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Psychiatric disorders
Depression
|
8.7%
2/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
8.3%
3/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
4.5%
1/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
5.0%
1/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
7.9%
3/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
13.0%
3/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
5.6%
2/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
50.0%
1/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
25.0%
1/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
5.3%
2/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
2.6%
1/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
2.8%
1/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
4.5%
1/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Reproductive system and breast disorders
Ejaculation disorder
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Reproductive system and breast disorders
Oedema genital
|
8.7%
2/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
26.1%
6/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
20.0%
4/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
21.1%
8/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
17.4%
4/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
19.4%
7/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
13.6%
3/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
17.4%
4/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
10.0%
2/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
18.4%
7/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
21.7%
5/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
16.7%
6/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
4.5%
1/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
25.0%
1/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
8.7%
2/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
5.0%
1/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
2.6%
1/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
4.3%
1/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
8.7%
2/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
5.0%
1/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
2.6%
1/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
8.7%
2/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
25.0%
1/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
5.0%
1/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
5.3%
2/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
4.3%
1/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
5.6%
2/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
8.7%
2/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
2.6%
1/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
2.8%
1/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
5.0%
1/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
2.6%
1/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
4.3%
1/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
4.5%
1/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
4.3%
1/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
2.6%
1/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
5.3%
2/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
8.3%
3/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
10.0%
2/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
4.3%
1/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
4.3%
1/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
2.8%
1/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
15.0%
3/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
8.7%
2/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
13.9%
5/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
4.5%
1/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
25.0%
1/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
5.3%
2/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
4.5%
1/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.7%
2/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
5.0%
1/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
10.5%
4/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
33.3%
2/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
26.1%
6/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
11.1%
4/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
9.1%
2/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
50.0%
1/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
25.0%
1/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.3%
1/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
10.0%
2/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
10.5%
4/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
37.5%
3/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
4.3%
1/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
2.8%
1/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
33.3%
2/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
50.0%
1/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
21.7%
5/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
5.0%
1/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
5.3%
2/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
4.5%
1/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
13.0%
3/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
2.8%
1/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
14.3%
1/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Vascular disorders
Deep vein thrombosis
|
4.3%
1/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
2.6%
1/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
12.5%
1/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
4.3%
1/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Vascular disorders
Hypertension
|
4.3%
1/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
5.0%
1/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
7.9%
3/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
5.6%
2/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
50.0%
1/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Vascular disorders
Hypotension
|
4.3%
1/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
5.0%
1/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
5.3%
2/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
8.7%
2/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
5.6%
2/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
9.1%
2/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Vascular disorders
Jugular vein thrombosis
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/20 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/38 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/7 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/8 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/23 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/36 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/22 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
16.7%
1/6 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/2 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
0.00%
0/4 • Participants were assessed for all-cause mortality from their randomization until their study completion (up to approximately 65 months). SAEs and other AEs were assessed from first dose to 100 days after last dose of study therapy (up to approximately 30 months).
The total number at risk for all-cause mortality represents all participants who were randomized and re-randomized. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants who received at least 1 dose of study medication.
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: Please Email
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER