Trial Outcomes & Findings for A Study of the Effectiveness and Safety of Nivolumab Compared to Bevacizumab and of Nivolumab With or Without Ipilimumab in Glioblastoma Patients (NCT NCT02017717)
NCT ID: NCT02017717
Last Updated: 2025-04-04
Results Overview
The percentage of participants who experienced a drug-related adverse event leading to drug discontinuation by worst grade (grade 5 being the worst) prior to complete four-dose treatment. Toxicities were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. MedDRA Version: 24.1
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
529 participants
Primary outcome timeframe
Includes events reported between first dose and 30 days after last dose of study therapy (up to 3 doses, up to approximately 2 months)
Results posted on
2025-04-04
Participant Flow
529 participants participated in the study. Of these 529 participants, 448 were randomized in the pre-treatment phase while 81 were directly treated in a non-randomized fashion. Of the 448 participants randomized, 423 moved to the treatment phase. The total number of treated participants was 504 (81 directly treated, 423 randomized and treated). GBM = Glioblastoma MGMT = O6-methylguanin-DNA-methyltransferase
Participant milestones
| Measure |
Cohort 1: Arm N1+I3
Nivolumab 1 mg/kg administered as a 60-minute intravenous (IV) infusion followed by ipilimumab 3 mg/kg 90-minute IV infusion every 3 weeks for 4 cycles, then nivolumab 3 mg/kg 60-minute IV every 2 weeks thereafter
|
Cohort 1: Arm N3
Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks
|
Cohort 1b: Arm N3+I1
Nivolumab 3 mg/kg administered as a 60-minute IV infusion followed by ipilimumab 1 mg/kg 90-minute IV infusion every 3 weeks for 4 cycles, then nivolumab 3 mg/kg 60-minute IV every 2 weeks thereafter
|
Part A Cohort 1c: Arm N3+RT+TMZ
Participants with newly diagnosed GBM: Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks with standard of care treatment including surgical resection and chemoradiation followed by 6 or more cycles of maintenance temozolomide
|
Part A Cohort 1d: Arm N3+RT
Participants with newly diagnosed unmethylated MGMT GBM: Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks with standard of care treatment including surgical resection and radiation therapy
|
Part B Cohort 1c: Arm N3+RT+TMZ
Participants with newly diagnosed GBM: Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks with standard of care treatment including surgical resection and chemoradiation followed by 6 or more cycles of maintenance temozolomide
|
Part B Cohort 1d: Arm N3+RT
Participants with newly diagnosed unmethylated MGMT GBM: Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks with standard of care treatment including surgical resection and radiation therapy
|
Cohort 2: Arm N3
Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks
|
Cohort 2: Arm B
Bevacizumab 10 mg/kg dosed every 2 weeks as 90-minute IV infusion for the first dose and 60-minute IV infusions for subsequent doses if the first infusion is tolerated
|
|---|---|---|---|---|---|---|---|---|---|
|
Before Treatment Period
STARTED
|
10
|
10
|
20
|
31
|
30
|
29
|
30
|
184
|
185
|
|
Before Treatment Period
Randomized
|
10
|
10
|
0
|
0
|
0
|
29
|
30
|
184
|
185
|
|
Before Treatment Period
COMPLETED
|
10
|
10
|
20
|
31
|
30
|
28
|
28
|
182
|
165
|
|
Before Treatment Period
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
1
|
2
|
2
|
20
|
|
Treatment Period
STARTED
|
10
|
10
|
20
|
31
|
30
|
28
|
28
|
182
|
165
|
|
Treatment Period
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period
NOT COMPLETED
|
10
|
10
|
20
|
31
|
30
|
28
|
28
|
182
|
165
|
Reasons for withdrawal
| Measure |
Cohort 1: Arm N1+I3
Nivolumab 1 mg/kg administered as a 60-minute intravenous (IV) infusion followed by ipilimumab 3 mg/kg 90-minute IV infusion every 3 weeks for 4 cycles, then nivolumab 3 mg/kg 60-minute IV every 2 weeks thereafter
|
Cohort 1: Arm N3
Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks
|
Cohort 1b: Arm N3+I1
Nivolumab 3 mg/kg administered as a 60-minute IV infusion followed by ipilimumab 1 mg/kg 90-minute IV infusion every 3 weeks for 4 cycles, then nivolumab 3 mg/kg 60-minute IV every 2 weeks thereafter
|
Part A Cohort 1c: Arm N3+RT+TMZ
Participants with newly diagnosed GBM: Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks with standard of care treatment including surgical resection and chemoradiation followed by 6 or more cycles of maintenance temozolomide
|
Part A Cohort 1d: Arm N3+RT
Participants with newly diagnosed unmethylated MGMT GBM: Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks with standard of care treatment including surgical resection and radiation therapy
|
Part B Cohort 1c: Arm N3+RT+TMZ
Participants with newly diagnosed GBM: Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks with standard of care treatment including surgical resection and chemoradiation followed by 6 or more cycles of maintenance temozolomide
|
Part B Cohort 1d: Arm N3+RT
Participants with newly diagnosed unmethylated MGMT GBM: Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks with standard of care treatment including surgical resection and radiation therapy
|
Cohort 2: Arm N3
Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks
|
Cohort 2: Arm B
Bevacizumab 10 mg/kg dosed every 2 weeks as 90-minute IV infusion for the first dose and 60-minute IV infusions for subsequent doses if the first infusion is tolerated
|
|---|---|---|---|---|---|---|---|---|---|
|
Before Treatment Period
Adverse Event unrelated to study drug
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Before Treatment Period
Participant request to stop therapy
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
5
|
|
Before Treatment Period
Participant withdrew consent
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
11
|
|
Before Treatment Period
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Before Treatment Period
Participant no longer met criteria
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
2
|
|
Before Treatment Period
other reason
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Treatment Period
Disease progression
|
7
|
9
|
12
|
20
|
26
|
16
|
22
|
165
|
135
|
|
Treatment Period
Study drug toxicity
|
3
|
0
|
1
|
4
|
4
|
5
|
3
|
7
|
11
|
|
Treatment Period
Death
|
0
|
0
|
1
|
0
|
0
|
2
|
0
|
0
|
0
|
|
Treatment Period
Adverse event unrelated to study drug
|
0
|
0
|
2
|
0
|
0
|
0
|
1
|
4
|
5
|
|
Treatment Period
Participant request to stop therapy
|
0
|
0
|
3
|
6
|
0
|
2
|
1
|
4
|
7
|
|
Treatment Period
Participant withdrew consent
|
0
|
0
|
1
|
0
|
0
|
2
|
0
|
1
|
4
|
|
Treatment Period
Participant no longer met criteria
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Treatment Period
Other reasons
|
0
|
0
|
0
|
1
|
0
|
1
|
1
|
1
|
1
|
|
Treatment Period
Maximum clinical benefit
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Treatment Period
Not reported
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Study of the Effectiveness and Safety of Nivolumab Compared to Bevacizumab and of Nivolumab With or Without Ipilimumab in Glioblastoma Patients
Baseline characteristics by cohort
| Measure |
Cohort 1: Arm N1+I3
n=10 Participants
Nivolumab 1 mg/kg administered as a 60-minute intravenous (IV) infusion followed by ipilimumab 3 mg/kg 90-minute IV infusion every 3 weeks for 4 cycles, then nivolumab 3 mg/kg 60-minute IV every 2 weeks thereafter
|
Cohort 1: Arm N3
n=10 Participants
Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks
|
Cohort 1b: Arm N3+I1
n=20 Participants
Nivolumab 3 mg/kg administered as a 60-minute IV infusion followed by ipilimumab 1 mg/kg 90-minute IV infusion every 3 weeks for 4 cycles, then nivolumab 3 mg/kg 60-minute IV every 2 weeks thereafter
|
Part A Cohort 1c: Arm N3+RT+TMZ
n=31 Participants
Participants with newly diagnosed GBM: Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks with standard of care treatment including surgical resection and chemoradiation followed by 6 or more cycles of maintenance temozolomide
|
Part A Cohort 1d: Arm N3+RT
n=30 Participants
Participants with newly diagnosed unmethylated MGMT GBM: Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks with standard of care treatment including surgical resection and radiation therapy
|
Part B Cohort 1c: Arm N3+RT+TMZ
n=29 Participants
Participants with newly diagnosed GBM: Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks with standard of care treatment including surgical resection and chemoradiation followed by 6 or more cycles of maintenance temozolomide
|
Part B Cohort 1d: Arm N3+RT
n=30 Participants
Participants with newly diagnosed unmethylated MGMT GBM: Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks with standard of care treatment including surgical resection and radiation therapy
|
Cohort 2: Arm N3
n=184 Participants
Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks
|
Cohort 2: Arm B
n=185 Participants
Bevacizumab 10 mg/kg dosed every 2 weeks as 90-minute IV infusion for the first dose and 60-minute IV infusions for subsequent doses if the first infusion is tolerated
|
Total
n=529 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
54.5 Years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
58.6 Years
STANDARD_DEVIATION 10.9 • n=7 Participants
|
55.0 Years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
56.5 Years
STANDARD_DEVIATION 11.3 • n=4 Participants
|
58.2 Years
STANDARD_DEVIATION 10.2 • n=21 Participants
|
57.3 Years
STANDARD_DEVIATION 12.7 • n=10 Participants
|
58.8 Years
STANDARD_DEVIATION 10.5 • n=115 Participants
|
55.0 Years
STANDARD_DEVIATION 11.3 • n=24 Participants
|
54.2 Years
STANDARD_DEVIATION 10.7 • n=42 Participants
|
55.4 Years
STANDARD_DEVIATION 11.1 • n=42 Participants
|
|
Age, Customized
< 65
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
22 Participants
n=10 Participants
|
19 Participants
n=115 Participants
|
142 Participants
n=24 Participants
|
156 Participants
n=42 Participants
|
414 Participants
n=42 Participants
|
|
Age, Customized
>= 65
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
11 Participants
n=115 Participants
|
42 Participants
n=24 Participants
|
29 Participants
n=42 Participants
|
115 Participants
n=42 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
10 Participants
n=10 Participants
|
9 Participants
n=115 Participants
|
68 Participants
n=24 Participants
|
66 Participants
n=42 Participants
|
187 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
19 Participants
n=10 Participants
|
21 Participants
n=115 Participants
|
116 Participants
n=24 Participants
|
119 Participants
n=42 Participants
|
342 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
4 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
10 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
28 Participants
n=10 Participants
|
29 Participants
n=115 Participants
|
86 Participants
n=24 Participants
|
88 Participants
n=42 Participants
|
327 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
94 Participants
n=24 Participants
|
96 Participants
n=42 Participants
|
192 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
2 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
2 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
White
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
27 Participants
n=10 Participants
|
28 Participants
n=115 Participants
|
176 Participants
n=24 Participants
|
181 Participants
n=42 Participants
|
502 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
4 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
10 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
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=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Includes events reported between first dose and 30 days after last dose of study therapy (up to 3 doses, up to approximately 2 months)Population: All Treated Participants in Cohorts 1, 1b, 1c and 1d Who Permanently Discontinued Study Medication Prior to Completing Four Doses
The percentage of participants who experienced a drug-related adverse event leading to drug discontinuation by worst grade (grade 5 being the worst) prior to complete four-dose treatment. Toxicities were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. MedDRA Version: 24.1
Outcome measures
| Measure |
Cohort 1: Arm N1+I3
n=6 Participants
Nivolumab 1 mg/kg administered as a 60-minute intravenous (IV) infusion followed by ipilimumab 3 mg/kg 90-minute IV infusion every 3 weeks for 4 cycles, then nivolumab 3 mg/kg 60-minute IV every 2 weeks thereafter
|
Cohort 1: Arm N3
n=4 Participants
Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks
|
Cohort 1b: Arm N3+I1
n=7 Participants
Nivolumab 3 mg/kg administered as a 60-minute IV infusion followed by ipilimumab 1 mg/kg 90-minute IV infusion every 3 weeks for 4 cycles, then nivolumab 3 mg/kg 60-minute IV every 2 weeks thereafter
|
Part A Cohort 1c: Arm N3+RT+TMZ
n=3 Participants
Participants with newly diagnosed GBM: Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks with standard of care treatment including surgical resection and chemoradiation followed by 6 or more cycles of maintenance temozolomide
|
Part A Cohort 1d: Arm N3+RT
n=1 Participants
Participants with newly diagnosed unmethylated MGMT GBM: Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks with standard of care treatment including surgical resection and radiation therapy
|
Part B Cohort 1c: Arm N3+RT+TMZ
n=4 Participants
Participants with newly diagnosed GBM: Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks with standard of care treatment including surgical resection and chemoradiation followed by 6 or more cycles of maintenance temozolomide
|
Part B Cohort 1d: Arm N3+RT
n=4 Participants
Participants with newly diagnosed unmethylated MGMT GBM: Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks with standard of care treatment including surgical resection and radiation therapy
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Drug-Related Adverse Events Leading to Discontinuation by Worst CTC Grade for All Treated Participants in Cohorts 1, 1b, 1c and 1d Who Permanently Discontinued Study Medication Prior to Completing Four Doses
Grade 1
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Drug-Related Adverse Events Leading to Discontinuation by Worst CTC Grade for All Treated Participants in Cohorts 1, 1b, 1c and 1d Who Permanently Discontinued Study Medication Prior to Completing Four Doses
Grade 2
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Drug-Related Adverse Events Leading to Discontinuation by Worst CTC Grade for All Treated Participants in Cohorts 1, 1b, 1c and 1d Who Permanently Discontinued Study Medication Prior to Completing Four Doses
Grade 3
|
16.7 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
66.7 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
50.0 Percentage of participants
|
|
Percentage of Participants With Drug-Related Adverse Events Leading to Discontinuation by Worst CTC Grade for All Treated Participants in Cohorts 1, 1b, 1c and 1d Who Permanently Discontinued Study Medication Prior to Completing Four Doses
Grade 4
|
33.3 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Drug-Related Adverse Events Leading to Discontinuation by Worst CTC Grade for All Treated Participants in Cohorts 1, 1b, 1c and 1d Who Permanently Discontinued Study Medication Prior to Completing Four Doses
Grade 5
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
PRIMARY outcome
Timeframe: From first dose to 30 days post last dose (up to approximately 34 months).Population: All Treated Participants in Cohorts 1, 1b, 1c and 1d
The percentage of participants who experienced an adverse event by worst grade in each treatment arm. Toxicities were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. MedDRA Version: 24.1
Outcome measures
| Measure |
Cohort 1: Arm N1+I3
n=10 Participants
Nivolumab 1 mg/kg administered as a 60-minute intravenous (IV) infusion followed by ipilimumab 3 mg/kg 90-minute IV infusion every 3 weeks for 4 cycles, then nivolumab 3 mg/kg 60-minute IV every 2 weeks thereafter
|
Cohort 1: Arm N3
n=10 Participants
Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks
|
Cohort 1b: Arm N3+I1
n=20 Participants
Nivolumab 3 mg/kg administered as a 60-minute IV infusion followed by ipilimumab 1 mg/kg 90-minute IV infusion every 3 weeks for 4 cycles, then nivolumab 3 mg/kg 60-minute IV every 2 weeks thereafter
|
Part A Cohort 1c: Arm N3+RT+TMZ
n=31 Participants
Participants with newly diagnosed GBM: Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks with standard of care treatment including surgical resection and chemoradiation followed by 6 or more cycles of maintenance temozolomide
|
Part A Cohort 1d: Arm N3+RT
n=30 Participants
Participants with newly diagnosed unmethylated MGMT GBM: Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks with standard of care treatment including surgical resection and radiation therapy
|
Part B Cohort 1c: Arm N3+RT+TMZ
n=28 Participants
Participants with newly diagnosed GBM: Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks with standard of care treatment including surgical resection and chemoradiation followed by 6 or more cycles of maintenance temozolomide
|
Part B Cohort 1d: Arm N3+RT
n=28 Participants
Participants with newly diagnosed unmethylated MGMT GBM: Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks with standard of care treatment including surgical resection and radiation therapy
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Adverse Events (Worst Grade) in Cohorts 1, 1b, 1c and 1d
Grade 1
|
0 Percentage of participants
|
20.0 Percentage of participants
|
5.0 Percentage of participants
|
6.5 Percentage of participants
|
13.3 Percentage of participants
|
3.6 Percentage of participants
|
17.9 Percentage of participants
|
|
Percentage of Participants With Adverse Events (Worst Grade) in Cohorts 1, 1b, 1c and 1d
Grade 2
|
10.0 Percentage of participants
|
30.0 Percentage of participants
|
25.0 Percentage of participants
|
12.9 Percentage of participants
|
26.7 Percentage of participants
|
28.6 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Participants With Adverse Events (Worst Grade) in Cohorts 1, 1b, 1c and 1d
Grade 3
|
70.0 Percentage of participants
|
40.0 Percentage of participants
|
50.0 Percentage of participants
|
58.1 Percentage of participants
|
33.3 Percentage of participants
|
50.0 Percentage of participants
|
35.7 Percentage of participants
|
|
Percentage of Participants With Adverse Events (Worst Grade) in Cohorts 1, 1b, 1c and 1d
Grade 4
|
20.0 Percentage of participants
|
10.0 Percentage of participants
|
20.0 Percentage of participants
|
22.6 Percentage of participants
|
20.0 Percentage of participants
|
10.7 Percentage of participants
|
21.4 Percentage of participants
|
|
Percentage of Participants With Adverse Events (Worst Grade) in Cohorts 1, 1b, 1c and 1d
Grade 5
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
3.3 Percentage of participants
|
3.6 Percentage of participants
|
0 Percentage of participants
|
PRIMARY outcome
Timeframe: From first dose to 30 days post last dose (up to approximately 34 months).Population: All Treated Participants in Cohorts 1, 1b, 1c and 1d
The percentage of participants who experienced a serious adverse event by worst grade in each treatment arm. Toxicities were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. MedDRA Version: 24.1
Outcome measures
| Measure |
Cohort 1: Arm N1+I3
n=10 Participants
Nivolumab 1 mg/kg administered as a 60-minute intravenous (IV) infusion followed by ipilimumab 3 mg/kg 90-minute IV infusion every 3 weeks for 4 cycles, then nivolumab 3 mg/kg 60-minute IV every 2 weeks thereafter
|
Cohort 1: Arm N3
n=10 Participants
Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks
|
Cohort 1b: Arm N3+I1
n=20 Participants
Nivolumab 3 mg/kg administered as a 60-minute IV infusion followed by ipilimumab 1 mg/kg 90-minute IV infusion every 3 weeks for 4 cycles, then nivolumab 3 mg/kg 60-minute IV every 2 weeks thereafter
|
Part A Cohort 1c: Arm N3+RT+TMZ
n=31 Participants
Participants with newly diagnosed GBM: Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks with standard of care treatment including surgical resection and chemoradiation followed by 6 or more cycles of maintenance temozolomide
|
Part A Cohort 1d: Arm N3+RT
n=30 Participants
Participants with newly diagnosed unmethylated MGMT GBM: Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks with standard of care treatment including surgical resection and radiation therapy
|
Part B Cohort 1c: Arm N3+RT+TMZ
n=28 Participants
Participants with newly diagnosed GBM: Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks with standard of care treatment including surgical resection and chemoradiation followed by 6 or more cycles of maintenance temozolomide
|
Part B Cohort 1d: Arm N3+RT
n=28 Participants
Participants with newly diagnosed unmethylated MGMT GBM: Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks with standard of care treatment including surgical resection and radiation therapy
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Serious Adverse Events (Worst Grade) in Cohorts 1, 1b, 1c and 1d
Grade 1
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
3.2 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Serious Adverse Events (Worst Grade) in Cohorts 1, 1b, 1c and 1d
Grade 2
|
0 Percentage of participants
|
10.0 Percentage of participants
|
5.0 Percentage of participants
|
0 Percentage of participants
|
16.7 Percentage of participants
|
3.6 Percentage of participants
|
10.7 Percentage of participants
|
|
Percentage of Participants With Serious Adverse Events (Worst Grade) in Cohorts 1, 1b, 1c and 1d
Grade 3
|
60.0 Percentage of participants
|
40.0 Percentage of participants
|
35.0 Percentage of participants
|
45.2 Percentage of participants
|
16.7 Percentage of participants
|
35.7 Percentage of participants
|
32.1 Percentage of participants
|
|
Percentage of Participants With Serious Adverse Events (Worst Grade) in Cohorts 1, 1b, 1c and 1d
Grade 5
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
3.3 Percentage of participants
|
3.6 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Serious Adverse Events (Worst Grade) in Cohorts 1, 1b, 1c and 1d
Grade 4
|
20.0 Percentage of participants
|
0 Percentage of participants
|
15.0 Percentage of participants
|
16.1 Percentage of participants
|
16.7 Percentage of participants
|
3.6 Percentage of participants
|
14.3 Percentage of participants
|
PRIMARY outcome
Timeframe: From first dose to 30 days post last dose (up to approximately 34 months).Population: All Treated Subjects in Cohorts 1, 1b, 1c and 1d with at least one on-treatment measurement of the corresponding laboratory parameter
The percentage of participants who experienced a laboratory abnormality of the liver in each treatment arm. MedDRA Version: 24.1 Aspartate aminotransferase (AST) Alanine aminotransferase (ALT) Upper Limit of Normal (ULN) Denominator corresponds to participants with at least on one treatment measurement of the corresponding laboratory parameter. Includes laboratory results reported after the first dose and within 30 days of last dose of study therapy.
Outcome measures
| Measure |
Cohort 1: Arm N1+I3
n=10 Participants
Nivolumab 1 mg/kg administered as a 60-minute intravenous (IV) infusion followed by ipilimumab 3 mg/kg 90-minute IV infusion every 3 weeks for 4 cycles, then nivolumab 3 mg/kg 60-minute IV every 2 weeks thereafter
|
Cohort 1: Arm N3
n=10 Participants
Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks
|
Cohort 1b: Arm N3+I1
n=19 Participants
Nivolumab 3 mg/kg administered as a 60-minute IV infusion followed by ipilimumab 1 mg/kg 90-minute IV infusion every 3 weeks for 4 cycles, then nivolumab 3 mg/kg 60-minute IV every 2 weeks thereafter
|
Part A Cohort 1c: Arm N3+RT+TMZ
n=31 Participants
Participants with newly diagnosed GBM: Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks with standard of care treatment including surgical resection and chemoradiation followed by 6 or more cycles of maintenance temozolomide
|
Part A Cohort 1d: Arm N3+RT
n=30 Participants
Participants with newly diagnosed unmethylated MGMT GBM: Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks with standard of care treatment including surgical resection and radiation therapy
|
Part B Cohort 1c: Arm N3+RT+TMZ
n=27 Participants
Participants with newly diagnosed GBM: Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks with standard of care treatment including surgical resection and chemoradiation followed by 6 or more cycles of maintenance temozolomide
|
Part B Cohort 1d: Arm N3+RT
n=27 Participants
Participants with newly diagnosed unmethylated MGMT GBM: Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks with standard of care treatment including surgical resection and radiation therapy
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Specific Laboratory Abnormalities in Liver Tests in Cohorts 1, 1b, 1c and 1d
ALT OR AST > 5*ULN
|
20.0 Percentage of participants
|
0.0 Percentage of participants
|
10.5 Percentage of participants
|
12.9 Percentage of participants
|
3.3 Percentage of participants
|
11.1 Percentage of participants
|
3.7 Percentage of participants
|
|
Percentage of Participants With Specific Laboratory Abnormalities in Liver Tests in Cohorts 1, 1b, 1c and 1d
ALT OR AST > 10*ULN
|
10.0 Percentage of participants
|
0.0 Percentage of participants
|
5.3 Percentage of participants
|
6.5 Percentage of participants
|
3.3 Percentage of participants
|
3.7 Percentage of participants
|
3.7 Percentage of participants
|
|
Percentage of Participants With Specific Laboratory Abnormalities in Liver Tests in Cohorts 1, 1b, 1c and 1d
ALT or AST > 3xULN w/ Tbili > 1.5*ULN within 1 day
|
10.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
3.7 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Specific Laboratory Abnormalities in Liver Tests in Cohorts 1, 1b, 1c and 1d
ALT or AST > 3*ULN w/ Tbili > 2*ULN within 30 days
|
10.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
3.7 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Specific Laboratory Abnormalities in Liver Tests in Cohorts 1, 1b, 1c and 1d
ALT OR AST > 3*ULN
|
30.0 Percentage of participants
|
0.0 Percentage of participants
|
15.8 Percentage of participants
|
22.6 Percentage of participants
|
10.0 Percentage of participants
|
18.5 Percentage of participants
|
14.8 Percentage of participants
|
|
Percentage of Participants With Specific Laboratory Abnormalities in Liver Tests in Cohorts 1, 1b, 1c and 1d
ALT OR AST > 20*ULN
|
10.0 Percentage of participants
|
0.0 Percentage of participants
|
5.3 Percentage of participants
|
3.2 Percentage of participants
|
3.3 Percentage of participants
|
0.0 Percentage of participants
|
3.7 Percentage of participants
|
|
Percentage of Participants With Specific Laboratory Abnormalities in Liver Tests in Cohorts 1, 1b, 1c and 1d
TOTAL BILIRUBIN (Tbili) > 2*ULN
|
10.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
7.4 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Specific Laboratory Abnormalities in Liver Tests in Cohorts 1, 1b, 1c and 1d
ALP > 1.5*ULN
|
10.0 Percentage of participants
|
10.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
3.3 Percentage of participants
|
0.0 Percentage of participants
|
3.7 Percentage of participants
|
|
Percentage of Participants With Specific Laboratory Abnormalities in Liver Tests in Cohorts 1, 1b, 1c and 1d
ALT or AST > 3*ULN w/ Tbili > 1.5*ULN within 30 days
|
10.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
3.7 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Specific Laboratory Abnormalities in Liver Tests in Cohorts 1, 1b, 1c and 1d
ALT or AST > 3xULN w/ Tbili > 2*ULN within 1 day
|
10.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
3.7 Percentage of participants
|
0.0 Percentage of participants
|
PRIMARY outcome
Timeframe: From first dose to 30 days post last dose (up to approximately 34 months).Population: All Treated Subjects in Cohorts 1, 1b, 1c and 1d with at Least One On-Treatment TSH measurement
The percentage of participants who experienced a laboratory abnormality of the thyroid in each treatment arm. MedDRA Version: 24.1 Free T3 (FT3) Free T4 (FT4) Lower Limit of Normal (LLN) (A) Within a 2-week window after the abnormal TSH test date. (B) Includes participants with TSH abnormality and with no FT3/FT4 test values in the 2-week window or with non-abnormal value(s) from only one of the two tests and no value from the other test.
Outcome measures
| Measure |
Cohort 1: Arm N1+I3
n=10 Participants
Nivolumab 1 mg/kg administered as a 60-minute intravenous (IV) infusion followed by ipilimumab 3 mg/kg 90-minute IV infusion every 3 weeks for 4 cycles, then nivolumab 3 mg/kg 60-minute IV every 2 weeks thereafter
|
Cohort 1: Arm N3
n=10 Participants
Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks
|
Cohort 1b: Arm N3+I1
n=19 Participants
Nivolumab 3 mg/kg administered as a 60-minute IV infusion followed by ipilimumab 1 mg/kg 90-minute IV infusion every 3 weeks for 4 cycles, then nivolumab 3 mg/kg 60-minute IV every 2 weeks thereafter
|
Part A Cohort 1c: Arm N3+RT+TMZ
n=30 Participants
Participants with newly diagnosed GBM: Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks with standard of care treatment including surgical resection and chemoradiation followed by 6 or more cycles of maintenance temozolomide
|
Part A Cohort 1d: Arm N3+RT
n=30 Participants
Participants with newly diagnosed unmethylated MGMT GBM: Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks with standard of care treatment including surgical resection and radiation therapy
|
Part B Cohort 1c: Arm N3+RT+TMZ
n=27 Participants
Participants with newly diagnosed GBM: Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks with standard of care treatment including surgical resection and chemoradiation followed by 6 or more cycles of maintenance temozolomide
|
Part B Cohort 1d: Arm N3+RT
n=27 Participants
Participants with newly diagnosed unmethylated MGMT GBM: Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks with standard of care treatment including surgical resection and radiation therapy
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Specific Laboratory Abnormalities in Thyroid Tests in Cohorts 1, 1b, 1c and 1d
TSH > ULN, WITH TSH <= ULN AT BASELINE
|
20.0 Percentage of participants
|
30.0 Percentage of participants
|
10.5 Percentage of participants
|
20.0 Percentage of participants
|
16.7 Percentage of participants
|
11.1 Percentage of participants
|
7.4 Percentage of participants
|
|
Percentage of Participants With Specific Laboratory Abnormalities in Thyroid Tests in Cohorts 1, 1b, 1c and 1d
TSH > ULN, WITH AT LEAST ONE FT3/FT4 TEST < LLN
|
20.0 Percentage of participants
|
30.0 Percentage of participants
|
10.5 Percentage of participants
|
13.3 Percentage of participants
|
13.3 Percentage of participants
|
7.4 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Specific Laboratory Abnormalities in Thyroid Tests in Cohorts 1, 1b, 1c and 1d
TSH < LLN
|
60.0 Percentage of participants
|
30.0 Percentage of participants
|
31.6 Percentage of participants
|
43.3 Percentage of participants
|
40.0 Percentage of participants
|
22.2 Percentage of participants
|
33.3 Percentage of participants
|
|
Percentage of Participants With Specific Laboratory Abnormalities in Thyroid Tests in Cohorts 1, 1b, 1c and 1d
TSH<LLN, LLN WITH AT LEAST ONE FT3/FT4 TEST>ULN
|
30.0 Percentage of participants
|
10.0 Percentage of participants
|
15.8 Percentage of participants
|
10.0 Percentage of participants
|
13.3 Percentage of participants
|
11.1 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Specific Laboratory Abnormalities in Thyroid Tests in Cohorts 1, 1b, 1c and 1d
TSH < LLN, WITH ALL OTHER FT3/FT4 TEST <= ULN
|
20.0 Percentage of participants
|
20.0 Percentage of participants
|
10.5 Percentage of participants
|
30.0 Percentage of participants
|
16.7 Percentage of participants
|
11.1 Percentage of participants
|
29.6 Percentage of participants
|
|
Percentage of Participants With Specific Laboratory Abnormalities in Thyroid Tests in Cohorts 1, 1b, 1c and 1d
TSH < LLN, WITH FT3/FT4 TEST MISSING
|
10.0 Percentage of participants
|
0.0 Percentage of participants
|
5.3 Percentage of participants
|
3.3 Percentage of participants
|
10.0 Percentage of participants
|
0.0 Percentage of participants
|
3.7 Percentage of participants
|
|
Percentage of Participants With Specific Laboratory Abnormalities in Thyroid Tests in Cohorts 1, 1b, 1c and 1d
TSH > ULN, WITH ALL OTHER FT3/FT4 TEST >= LLN
|
0.0 Percentage of participants
|
10.0 Percentage of participants
|
0.0 Percentage of participants
|
6.7 Percentage of participants
|
0.0 Percentage of participants
|
3.7 Percentage of participants
|
7.4 Percentage of participants
|
|
Percentage of Participants With Specific Laboratory Abnormalities in Thyroid Tests in Cohorts 1, 1b, 1c and 1d
TSH < LLN, WITH TSH >= LLN AT BASELINE
|
60.0 Percentage of participants
|
30.0 Percentage of participants
|
31.6 Percentage of participants
|
33.3 Percentage of participants
|
40.0 Percentage of participants
|
18.5 Percentage of participants
|
18.5 Percentage of participants
|
|
Percentage of Participants With Specific Laboratory Abnormalities in Thyroid Tests in Cohorts 1, 1b, 1c and 1d
TSH > ULN, WITH FT3/FT4 TEST MISSING
|
0.0 Percentage of participants
|
10.0 Percentage of participants
|
0.0 Percentage of participants
|
3.3 Percentage of participants
|
3.3 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Specific Laboratory Abnormalities in Thyroid Tests in Cohorts 1, 1b, 1c and 1d
TSH > ULN
|
20.0 Percentage of participants
|
50.0 Percentage of participants
|
10.5 Percentage of participants
|
23.3 Percentage of participants
|
16.7 Percentage of participants
|
11.1 Percentage of participants
|
7.4 Percentage of participants
|
PRIMARY outcome
Timeframe: Time between the date of randomization and the date of death due to any cause (up to up to 17Jun2019, approximately 5 years)Population: All Randomized Participants in Cohort 2
OS was measured in months from the time of randomization to the event date (death) due to any cause. A participant who has not died will be censored at the last known alive date. Based on Kaplan-Meier Estimates. Hazard ratio from Cox proportional hazard model stratified by presence of measurable lesions at baseline per IVRS. P-value from log-rank test stratified by presence of measurable lesions at baseline per IVRS.
Outcome measures
| Measure |
Cohort 1: Arm N1+I3
n=184 Participants
Nivolumab 1 mg/kg administered as a 60-minute intravenous (IV) infusion followed by ipilimumab 3 mg/kg 90-minute IV infusion every 3 weeks for 4 cycles, then nivolumab 3 mg/kg 60-minute IV every 2 weeks thereafter
|
Cohort 1: Arm N3
n=185 Participants
Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks
|
Cohort 1b: Arm N3+I1
Nivolumab 3 mg/kg administered as a 60-minute IV infusion followed by ipilimumab 1 mg/kg 90-minute IV infusion every 3 weeks for 4 cycles, then nivolumab 3 mg/kg 60-minute IV every 2 weeks thereafter
|
Part A Cohort 1c: Arm N3+RT+TMZ
Participants with newly diagnosed GBM: Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks with standard of care treatment including surgical resection and chemoradiation followed by 6 or more cycles of maintenance temozolomide
|
Part A Cohort 1d: Arm N3+RT
Participants with newly diagnosed unmethylated MGMT GBM: Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks with standard of care treatment including surgical resection and radiation therapy
|
Part B Cohort 1c: Arm N3+RT+TMZ
Participants with newly diagnosed GBM: Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks with standard of care treatment including surgical resection and chemoradiation followed by 6 or more cycles of maintenance temozolomide
|
Part B Cohort 1d: Arm N3+RT
Participants with newly diagnosed unmethylated MGMT GBM: Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks with standard of care treatment including surgical resection and radiation therapy
|
|---|---|---|---|---|---|---|---|
|
Overall Survival (OS) for Cohort 2
|
9.77 Months
Interval 8.21 to 11.83
|
10.05 Months
Interval 9.0 to 11.99
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From randomization to 12 months following randomizationPopulation: All Randomized Participants in Cohort 2
OS(12) is measured as the percentage of participants alive at 12 months per Kaplan-Meier curve of OS. Z test with variance estimation based on Greenwood formula using log(-log) transformation.
Outcome measures
| Measure |
Cohort 1: Arm N1+I3
n=184 Participants
Nivolumab 1 mg/kg administered as a 60-minute intravenous (IV) infusion followed by ipilimumab 3 mg/kg 90-minute IV infusion every 3 weeks for 4 cycles, then nivolumab 3 mg/kg 60-minute IV every 2 weeks thereafter
|
Cohort 1: Arm N3
n=185 Participants
Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks
|
Cohort 1b: Arm N3+I1
Nivolumab 3 mg/kg administered as a 60-minute IV infusion followed by ipilimumab 1 mg/kg 90-minute IV infusion every 3 weeks for 4 cycles, then nivolumab 3 mg/kg 60-minute IV every 2 weeks thereafter
|
Part A Cohort 1c: Arm N3+RT+TMZ
Participants with newly diagnosed GBM: Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks with standard of care treatment including surgical resection and chemoradiation followed by 6 or more cycles of maintenance temozolomide
|
Part A Cohort 1d: Arm N3+RT
Participants with newly diagnosed unmethylated MGMT GBM: Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks with standard of care treatment including surgical resection and radiation therapy
|
Part B Cohort 1c: Arm N3+RT+TMZ
Participants with newly diagnosed GBM: Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks with standard of care treatment including surgical resection and chemoradiation followed by 6 or more cycles of maintenance temozolomide
|
Part B Cohort 1d: Arm N3+RT
Participants with newly diagnosed unmethylated MGMT GBM: Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks with standard of care treatment including surgical resection and radiation therapy
|
|---|---|---|---|---|---|---|---|
|
Overall Survival (OS) at 12 Months for Cohort 2
|
41.8 Percentage of Participants
Interval 34.7 to 48.8
|
42.4 Percentage of Participants
Interval 34.9 to 49.6
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Time between the date of randomization and the date of death due to any cause (up to approximately 10 years and 5 months)Population: All Randomized (Part B) or Treated (Part A) Participants in Cohorts 1c and 1d
OS was measured in months from the time of randomization (Part B) or time of treatment (Part A) to the event date (death) due to any cause. A participant who has not died will be censored at the last known alive date. Based on Kaplan-Meier Estimates.
Outcome measures
| Measure |
Cohort 1: Arm N1+I3
n=31 Participants
Nivolumab 1 mg/kg administered as a 60-minute intravenous (IV) infusion followed by ipilimumab 3 mg/kg 90-minute IV infusion every 3 weeks for 4 cycles, then nivolumab 3 mg/kg 60-minute IV every 2 weeks thereafter
|
Cohort 1: Arm N3
n=30 Participants
Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks
|
Cohort 1b: Arm N3+I1
n=28 Participants
Nivolumab 3 mg/kg administered as a 60-minute IV infusion followed by ipilimumab 1 mg/kg 90-minute IV infusion every 3 weeks for 4 cycles, then nivolumab 3 mg/kg 60-minute IV every 2 weeks thereafter
|
Part A Cohort 1c: Arm N3+RT+TMZ
n=28 Participants
Participants with newly diagnosed GBM: Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks with standard of care treatment including surgical resection and chemoradiation followed by 6 or more cycles of maintenance temozolomide
|
Part A Cohort 1d: Arm N3+RT
Participants with newly diagnosed unmethylated MGMT GBM: Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks with standard of care treatment including surgical resection and radiation therapy
|
Part B Cohort 1c: Arm N3+RT+TMZ
Participants with newly diagnosed GBM: Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks with standard of care treatment including surgical resection and chemoradiation followed by 6 or more cycles of maintenance temozolomide
|
Part B Cohort 1d: Arm N3+RT
Participants with newly diagnosed unmethylated MGMT GBM: Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks with standard of care treatment including surgical resection and radiation therapy
|
|---|---|---|---|---|---|---|---|
|
Overall Survival (OS) for Cohorts 1c and 1d
|
22.08 Months
Interval 16.13 to 32.39
|
14.41 Months
Interval 12.55 to 17.31
|
15.95 Months
Interval 10.35 to 18.3
|
13.96 Months
Interval 10.81 to 18.14
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Time from randomization to the date of the first documented tumor progression or death due to any cause (up to approximately 10 years and 5 months)Population: All Randomized Participants in Cohort 2
PFS was measured in months from the time of randomization to the date of the first documented tumor progression or death due to any cause. Based on Kaplan-Meier Estimates. Hazard ratio from Cox proportional hazard model stratified by presence of measurable lesions at baseline per IVRS.
Outcome measures
| Measure |
Cohort 1: Arm N1+I3
n=184 Participants
Nivolumab 1 mg/kg administered as a 60-minute intravenous (IV) infusion followed by ipilimumab 3 mg/kg 90-minute IV infusion every 3 weeks for 4 cycles, then nivolumab 3 mg/kg 60-minute IV every 2 weeks thereafter
|
Cohort 1: Arm N3
n=185 Participants
Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks
|
Cohort 1b: Arm N3+I1
Nivolumab 3 mg/kg administered as a 60-minute IV infusion followed by ipilimumab 1 mg/kg 90-minute IV infusion every 3 weeks for 4 cycles, then nivolumab 3 mg/kg 60-minute IV every 2 weeks thereafter
|
Part A Cohort 1c: Arm N3+RT+TMZ
Participants with newly diagnosed GBM: Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks with standard of care treatment including surgical resection and chemoradiation followed by 6 or more cycles of maintenance temozolomide
|
Part A Cohort 1d: Arm N3+RT
Participants with newly diagnosed unmethylated MGMT GBM: Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks with standard of care treatment including surgical resection and radiation therapy
|
Part B Cohort 1c: Arm N3+RT+TMZ
Participants with newly diagnosed GBM: Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks with standard of care treatment including surgical resection and chemoradiation followed by 6 or more cycles of maintenance temozolomide
|
Part B Cohort 1d: Arm N3+RT
Participants with newly diagnosed unmethylated MGMT GBM: Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks with standard of care treatment including surgical resection and radiation therapy
|
|---|---|---|---|---|---|---|---|
|
Progression Free Survival (PFS) for Cohort 2
|
1.51 Months
Interval 1.48 to 1.61
|
3.61 Months
Interval 2.99 to 4.6
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Time from randomization to the date of the first documented tumor progression or death due to any cause (up to approximately 10 years and 5 months)Population: All Response Evaluable Participants in Cohort 2
ORR was measured by the percentage of participants whose best overall response (BOR) is confirmed Complete Response (CR) or Partial Response (PR) divided by response evaluable participants. The best overall response (BOR) is determined once all the data for the participant is known. BOR is defined as the best response designation, as determined by investigators, recorded between the date of randomization and the date of objectively documented progression per RANO criteria, the date of subsequent therapy, or date of surgical resection, whichever occurs first. Confidence interval based on the Clopper and Pearson method. For the comparison of the odds ratio of Nivolumab over Bevacizumab, the Cochran-Mantel-Haenszel (CMH) method of weighting was utilized.
Outcome measures
| Measure |
Cohort 1: Arm N1+I3
n=153 Participants
Nivolumab 1 mg/kg administered as a 60-minute intravenous (IV) infusion followed by ipilimumab 3 mg/kg 90-minute IV infusion every 3 weeks for 4 cycles, then nivolumab 3 mg/kg 60-minute IV every 2 weeks thereafter
|
Cohort 1: Arm N3
n=156 Participants
Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks
|
Cohort 1b: Arm N3+I1
Nivolumab 3 mg/kg administered as a 60-minute IV infusion followed by ipilimumab 1 mg/kg 90-minute IV infusion every 3 weeks for 4 cycles, then nivolumab 3 mg/kg 60-minute IV every 2 weeks thereafter
|
Part A Cohort 1c: Arm N3+RT+TMZ
Participants with newly diagnosed GBM: Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks with standard of care treatment including surgical resection and chemoradiation followed by 6 or more cycles of maintenance temozolomide
|
Part A Cohort 1d: Arm N3+RT
Participants with newly diagnosed unmethylated MGMT GBM: Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks with standard of care treatment including surgical resection and radiation therapy
|
Part B Cohort 1c: Arm N3+RT+TMZ
Participants with newly diagnosed GBM: Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks with standard of care treatment including surgical resection and chemoradiation followed by 6 or more cycles of maintenance temozolomide
|
Part B Cohort 1d: Arm N3+RT
Participants with newly diagnosed unmethylated MGMT GBM: Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks with standard of care treatment including surgical resection and radiation therapy
|
|---|---|---|---|---|---|---|---|
|
Objective Response Rate (ORR) for Cohort 2
|
7.8 Percentage of participants
Interval 4.1 to 13.3
|
23.1 Percentage of participants
Interval 16.7 to 30.5
|
—
|
—
|
—
|
—
|
—
|
POST_HOC outcome
Timeframe: Time between the date of randomization and the date of death due to any cause (up to approximately 10 years and 5 months)Population: All Randomized Participants in Cohort 2
OS was measured in months from the time of randomization to the event date (death) due to any cause. A participant who has not died will be censored at the last known alive date. Based on Kaplan-Meier Estimates. Hazard ratio from Cox proportional hazard model stratified by presence of measurable lesions at baseline per IVRS. P-value from log-rank test stratified by presence of measurable lesions at baseline per IVRS.
Outcome measures
| Measure |
Cohort 1: Arm N1+I3
n=184 Participants
Nivolumab 1 mg/kg administered as a 60-minute intravenous (IV) infusion followed by ipilimumab 3 mg/kg 90-minute IV infusion every 3 weeks for 4 cycles, then nivolumab 3 mg/kg 60-minute IV every 2 weeks thereafter
|
Cohort 1: Arm N3
n=185 Participants
Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks
|
Cohort 1b: Arm N3+I1
Nivolumab 3 mg/kg administered as a 60-minute IV infusion followed by ipilimumab 1 mg/kg 90-minute IV infusion every 3 weeks for 4 cycles, then nivolumab 3 mg/kg 60-minute IV every 2 weeks thereafter
|
Part A Cohort 1c: Arm N3+RT+TMZ
Participants with newly diagnosed GBM: Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks with standard of care treatment including surgical resection and chemoradiation followed by 6 or more cycles of maintenance temozolomide
|
Part A Cohort 1d: Arm N3+RT
Participants with newly diagnosed unmethylated MGMT GBM: Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks with standard of care treatment including surgical resection and radiation therapy
|
Part B Cohort 1c: Arm N3+RT+TMZ
Participants with newly diagnosed GBM: Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks with standard of care treatment including surgical resection and chemoradiation followed by 6 or more cycles of maintenance temozolomide
|
Part B Cohort 1d: Arm N3+RT
Participants with newly diagnosed unmethylated MGMT GBM: Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks with standard of care treatment including surgical resection and radiation therapy
|
|---|---|---|---|---|---|---|---|
|
Overall Survival (OS) for Cohort 2 - Extended Collection
|
9.77 Months
Interval 8.21 to 11.83
|
10.05 Months
Interval 9.0 to 11.99
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Cohort 1: Arm N1+I3
Serious events: 8 serious events
Other events: 10 other events
Deaths: 10 deaths
Cohort 1: Arm N3
Serious events: 7 serious events
Other events: 10 other events
Deaths: 9 deaths
Cohort 1b: Arm N3+I1
Serious events: 15 serious events
Other events: 20 other events
Deaths: 20 deaths
Part A Cohort 1c: Arm N3+RT+TMZ
Serious events: 24 serious events
Other events: 31 other events
Deaths: 29 deaths
Part A Cohort 1d: Arm N3+RT
Serious events: 19 serious events
Other events: 29 other events
Deaths: 30 deaths
Part B Cohort 1c: Arm N3+RT+TMZ
Serious events: 16 serious events
Other events: 27 other events
Deaths: 28 deaths
Part B Cohort 1d: Arm N3+RT
Serious events: 19 serious events
Other events: 27 other events
Deaths: 28 deaths
Cohort 2: Arm N3
Serious events: 117 serious events
Other events: 168 other events
Deaths: 180 deaths
Cohort 2: Arm B
Serious events: 94 serious events
Other events: 148 other events
Deaths: 166 deaths
Serious adverse events
| Measure |
Cohort 1: Arm N1+I3
n=10 participants at risk
Nivolumab 1 mg/kg administered as a 60-minute intravenous (IV) infusion followed by ipilimumab 3 mg/kg 90-minute IV infusion every 3 weeks for 4 cycles, then nivolumab 3 mg/kg 60-minute IV every 2 weeks thereafter
|
Cohort 1: Arm N3
n=10 participants at risk
Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks
|
Cohort 1b: Arm N3+I1
n=20 participants at risk
Nivolumab 3 mg/kg administered as a 60-minute IV infusion followed by ipilimumab 1 mg/kg 90-minute IV infusion every 3 weeks for 4 cycles, then nivolumab 3 mg/kg 60-minute IV every 2 weeks thereafter
|
Part A Cohort 1c: Arm N3+RT+TMZ
n=31 participants at risk
Participants with newly diagnosed GBM: Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks with standard of care treatment including surgical resection and chemoradiation followed by 6 or more cycles of maintenance temozolomide
|
Part A Cohort 1d: Arm N3+RT
n=30 participants at risk
Participants with newly diagnosed unmethylated MGMT GBM: Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks with standard of care treatment including surgical resection and radiation therapy
|
Part B Cohort 1c: Arm N3+RT+TMZ
n=28 participants at risk
Participants with newly diagnosed GBM: Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks with standard of care treatment including surgical resection and chemoradiation followed by 6 or more cycles of maintenance temozolomide
|
Part B Cohort 1d: Arm N3+RT
n=28 participants at risk
Participants with newly diagnosed unmethylated MGMT GBM: Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks with standard of care treatment including surgical resection and radiation therapy
|
Cohort 2: Arm N3
n=182 participants at risk
Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks
|
Cohort 2: Arm B
n=165 participants at risk
Bevacizumab 10 mg/kg dosed every 2 weeks as 90-minute IV infusion for the first dose and 60-minute IV infusions for subsequent doses if the first infusion is tolerated
|
|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.2%
1/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.55%
1/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.2%
1/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.3%
1/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
7.1%
2/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.2%
1/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
6.5%
2/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.2%
1/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
1.1%
2/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.61%
1/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.3%
1/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.55%
1/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Cardiac disorders
Bradycardia
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
5.0%
1/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Cardiac disorders
Sinus tachycardia
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Endocrine disorders
Autoimmune hypothyroidism
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.55%
1/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Endocrine disorders
Autoimmune thyroiditis
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
5.0%
1/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Endocrine disorders
Hyperthyroidism
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.2%
1/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.3%
1/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Endocrine disorders
Hypothyroidism
|
20.0%
2/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Eye disorders
Eye movement disorder
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Eye disorders
Visual impairment
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
7.1%
2/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.55%
1/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Gastrointestinal disorders
Autoimmune pancreatitis
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.55%
1/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Gastrointestinal disorders
Colitis
|
20.0%
2/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
5.0%
1/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Gastrointestinal disorders
Diarrhoea
|
20.0%
2/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
2/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
5.0%
1/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.2%
1/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.2%
1/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.55%
1/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.2%
1/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.61%
1/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.55%
1/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.55%
1/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.61%
1/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Gastrointestinal disorders
Pancreatitis
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.2%
1/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
5.0%
1/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
1.1%
2/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.61%
1/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
General disorders
Asthenia
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
5.0%
1/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.55%
1/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
General disorders
Fatigue
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
2/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.55%
1/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.61%
1/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
General disorders
Gait disturbance
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.3%
1/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
General disorders
General physical health deterioration
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
1.1%
2/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
2.4%
4/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
General disorders
Impaired healing
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
1.1%
2/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
General disorders
Necrosis
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.3%
1/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.55%
1/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
General disorders
Oedema
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.55%
1/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
General disorders
Performance status decreased
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.55%
1/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
General disorders
Pyrexia
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
12.9%
4/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.3%
1/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
7.1%
2/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
1.6%
3/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
1.2%
2/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
General disorders
Sudden death
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Hepatobiliary disorders
Cholecystitis
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.61%
1/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Hepatobiliary disorders
Immune-mediated hepatitis
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.61%
1/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Immune system disorders
Contrast media allergy
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.61%
1/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.55%
1/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.55%
1/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Infections and infestations
Brain abscess
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.55%
1/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Infections and infestations
Bronchitis
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.61%
1/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Infections and infestations
Cellulitis
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.2%
1/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
6.7%
2/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.2%
1/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Infections and infestations
Cystitis
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.55%
1/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Infections and infestations
Encephalitis
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.55%
1/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Infections and infestations
Encephalitis herpes
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Infections and infestations
Graft infection
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.55%
1/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Infections and infestations
Groin abscess
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.61%
1/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Infections and infestations
Herpes simplex encephalitis
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Infections and infestations
Oesophageal infection
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Infections and infestations
Pneumonia
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
5.0%
1/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
16.1%
5/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.7%
3/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
2.2%
4/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
1.2%
2/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Infections and infestations
Pneumonia aspiration
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.55%
1/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.55%
1/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Infections and infestations
Sepsis
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
7.1%
2/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
1.1%
2/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.61%
1/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Infections and infestations
Septic shock
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Infections and infestations
Sinusitis
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.2%
1/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.61%
1/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.61%
1/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Infections and infestations
Upper respiratory tract infection
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.2%
1/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.3%
1/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.55%
1/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
2/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.3%
1/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
1.6%
3/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.61%
1/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.55%
1/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.55%
1/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
5.0%
1/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.3%
1/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Injury, poisoning and procedural complications
Procedural haemorrhage
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.61%
1/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.61%
1/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Investigations
Alanine aminotransferase increased
|
20.0%
2/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
5.0%
1/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
6.5%
2/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.3%
1/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.55%
1/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Investigations
Aspartate aminotransferase increased
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
5.0%
1/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
6.5%
2/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
6.7%
2/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.55%
1/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.3%
1/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Investigations
Blood bilirubin increased
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.3%
1/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.61%
1/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Investigations
Influenza B virus test positive
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Investigations
Lipase increased
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Investigations
Platelet count decreased
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
5.0%
1/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Investigations
Transaminases increased
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.55%
1/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Investigations
White blood cell count decreased
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
5.0%
1/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Metabolism and nutrition disorders
Decreased appetite
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.3%
1/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
6.5%
2/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.55%
1/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
5.0%
1/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.2%
1/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.2%
1/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.61%
1/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.61%
1/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.2%
1/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.61%
1/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.3%
1/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Musculoskeletal and connective tissue disorders
Haematoma muscle
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.3%
1/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Musculoskeletal and connective tissue disorders
Mobility decreased
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.55%
1/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
1.2%
2/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
15.0%
3/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
6.7%
2/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.55%
1/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal adenoma
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.55%
1/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma multiforme
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.55%
1/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal proliferative breast lesion
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.2%
1/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
20.0%
2/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
20.0%
2/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
40.0%
8/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
38.7%
12/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
30.0%
9/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
14.3%
4/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
25.0%
7/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
35.2%
64/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
32.1%
53/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to spine
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.2%
1/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.55%
1/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour flare
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
5.0%
1/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
9.7%
3/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
6.7%
2/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.7%
3/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
7.1%
2/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
1.1%
2/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.55%
1/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Nervous system disorders
Amnesia
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.61%
1/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Nervous system disorders
Aphasia
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.2%
1/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
2.2%
4/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Nervous system disorders
Ataxia
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Nervous system disorders
Brain oedema
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
5.0%
1/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.2%
1/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.3%
1/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
2.7%
5/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.61%
1/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.55%
1/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.61%
1/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
1.2%
2/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Nervous system disorders
Cerebrospinal fluid leakage
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.55%
1/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
5.0%
1/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.55%
1/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
1.2%
2/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
7.1%
2/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.55%
1/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
1.2%
2/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Nervous system disorders
Demyelination
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.55%
1/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
2/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.55%
1/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Nervous system disorders
Dizziness
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
5.0%
1/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
5.0%
1/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
6.5%
2/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.3%
1/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
1.1%
2/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
1.8%
3/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.3%
1/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
2.7%
5/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Nervous system disorders
Headache
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
15.0%
3/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
6.5%
2/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
17.9%
5/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
5.5%
10/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
1.2%
2/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Nervous system disorders
Hemianopia homonymous
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Nervous system disorders
Hemiparesis
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
5.0%
1/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
6.7%
2/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
2.7%
5/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
1.8%
3/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Nervous system disorders
Hydrocephalus
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.2%
1/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
1.1%
2/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
5.0%
1/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
1.2%
2/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Nervous system disorders
Lethargy
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.2%
1/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
6.7%
2/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.3%
1/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Nervous system disorders
Nervous system disorder
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.55%
1/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.61%
1/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Nervous system disorders
Neurological decompensation
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.55%
1/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.61%
1/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Nervous system disorders
Parkinson's disease
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.55%
1/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Nervous system disorders
Presyncope
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.55%
1/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Nervous system disorders
Pyramidal tract syndrome
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.2%
1/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Nervous system disorders
Seizure
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
5.0%
1/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
16.1%
5/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
13.3%
4/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
14.3%
4/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
7.1%
2/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
9.3%
17/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
6.7%
11/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Nervous system disorders
Slow speech
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.61%
1/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Nervous system disorders
Somnolence
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Nervous system disorders
Status epilepticus
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.55%
1/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Nervous system disorders
Syncope
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
2/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.2%
1/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.61%
1/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.55%
1/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Nervous system disorders
Vasogenic cerebral oedema
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.3%
1/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
1.1%
2/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Psychiatric disorders
Agitation
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.61%
1/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Psychiatric disorders
Confusional state
|
20.0%
2/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
20.0%
2/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
2/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
12.9%
4/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
3/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
1.6%
3/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Psychiatric disorders
Delirium
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
5.0%
1/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.55%
1/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.61%
1/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.61%
1/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Renal and urinary disorders
Acute kidney injury
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.3%
1/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.55%
1/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.55%
1/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.3%
1/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.61%
1/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.55%
1/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
5.0%
1/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.2%
1/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
7.1%
2/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.61%
1/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Respiratory, thoracic and mediastinal disorders
Granulomatous pneumonitis
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.55%
1/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.55%
1/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
5.0%
1/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
5.0%
1/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
2.2%
4/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.61%
1/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.61%
1/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
2/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
1.6%
3/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.0%
5/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
5.0%
1/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Skin and subcutaneous tissue disorders
Dermatitis bullous
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Skin and subcutaneous tissue disorders
Drug reaction with eosinophilia and systemic symptoms
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Skin and subcutaneous tissue disorders
Lichen planus
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.3%
1/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.55%
1/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.2%
1/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.3%
1/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Skin and subcutaneous tissue disorders
Stevens-Johnson syndrome
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.3%
1/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
1.1%
2/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Vascular disorders
Embolism
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.3%
1/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.55%
1/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.61%
1/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Vascular disorders
Flushing
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Vascular disorders
Hypertension
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.61%
1/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Vascular disorders
Hypotension
|
20.0%
2/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.3%
1/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Vascular disorders
Ischaemia
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.55%
1/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
Other adverse events
| Measure |
Cohort 1: Arm N1+I3
n=10 participants at risk
Nivolumab 1 mg/kg administered as a 60-minute intravenous (IV) infusion followed by ipilimumab 3 mg/kg 90-minute IV infusion every 3 weeks for 4 cycles, then nivolumab 3 mg/kg 60-minute IV every 2 weeks thereafter
|
Cohort 1: Arm N3
n=10 participants at risk
Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks
|
Cohort 1b: Arm N3+I1
n=20 participants at risk
Nivolumab 3 mg/kg administered as a 60-minute IV infusion followed by ipilimumab 1 mg/kg 90-minute IV infusion every 3 weeks for 4 cycles, then nivolumab 3 mg/kg 60-minute IV every 2 weeks thereafter
|
Part A Cohort 1c: Arm N3+RT+TMZ
n=31 participants at risk
Participants with newly diagnosed GBM: Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks with standard of care treatment including surgical resection and chemoradiation followed by 6 or more cycles of maintenance temozolomide
|
Part A Cohort 1d: Arm N3+RT
n=30 participants at risk
Participants with newly diagnosed unmethylated MGMT GBM: Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks with standard of care treatment including surgical resection and radiation therapy
|
Part B Cohort 1c: Arm N3+RT+TMZ
n=28 participants at risk
Participants with newly diagnosed GBM: Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks with standard of care treatment including surgical resection and chemoradiation followed by 6 or more cycles of maintenance temozolomide
|
Part B Cohort 1d: Arm N3+RT
n=28 participants at risk
Participants with newly diagnosed unmethylated MGMT GBM: Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks with standard of care treatment including surgical resection and radiation therapy
|
Cohort 2: Arm N3
n=182 participants at risk
Nivolumab 3 mg/kg dosed as 60-minute IV infusion every 2 weeks
|
Cohort 2: Arm B
n=165 participants at risk
Bevacizumab 10 mg/kg dosed every 2 weeks as 90-minute IV infusion for the first dose and 60-minute IV infusions for subsequent doses if the first infusion is tolerated
|
|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
2/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
22.6%
7/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.3%
1/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
7.1%
2/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
14.3%
4/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
4.4%
8/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
2.4%
4/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.61%
1/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Blood and lymphatic system disorders
Lymphopenia
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
9.7%
3/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.3%
1/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
7.1%
2/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.3%
6/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
2.4%
4/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
17.9%
5/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
1.1%
2/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
1.8%
3/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
5.0%
1/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Cardiac disorders
Palpitations
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
6.5%
2/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.61%
1/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
2/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.55%
1/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
1.2%
2/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Ear and labyrinth disorders
Ear congestion
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.2%
1/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
6.7%
2/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Ear and labyrinth disorders
Tinnitus
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.2%
1/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.3%
1/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
7.1%
2/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.55%
1/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.61%
1/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.2%
1/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.3%
1/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
7.1%
2/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
1.6%
3/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
1.8%
3/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Endocrine disorders
Cushingoid
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
5.0%
1/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.2%
1/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
1.1%
2/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
1.2%
2/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Endocrine disorders
Endocrine disorder
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
6.7%
2/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Endocrine disorders
Hyperthyroidism
|
20.0%
2/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
5.0%
1/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
6.5%
2/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
3/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
2.7%
5/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Endocrine disorders
Hypothyroidism
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
20.0%
2/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
5.0%
1/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
9.7%
3/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
3/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
7.1%
2/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.7%
3/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
4.9%
9/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
1.2%
2/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Eye disorders
Blepharitis
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Eye disorders
Diplopia
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
7.1%
2/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.55%
1/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.61%
1/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Eye disorders
Dry eye
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
5.0%
1/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
6.5%
2/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.3%
1/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
7.1%
2/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
1.1%
2/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Eye disorders
Eyelid ptosis
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
5.0%
1/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
7.1%
2/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
1.1%
2/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Eye disorders
Night blindness
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Eye disorders
Optic nerve disorder
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
20.0%
2/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Eye disorders
Vision blurred
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
19.4%
6/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
3/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
2.7%
5/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
2.4%
4/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Eye disorders
Visual field defect
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
5.0%
1/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
9.7%
3/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
7.1%
2/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
1.6%
3/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
1.8%
3/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Eye disorders
Visual impairment
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
5.0%
1/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.2%
1/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
7.1%
2/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
2.2%
4/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
7.1%
2/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
15.0%
3/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
12.9%
4/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
3/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
7.1%
2/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.7%
3/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
9.3%
17/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.0%
5/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Gastrointestinal disorders
Anal incontinence
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
2/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
7.1%
2/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
2.2%
4/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.61%
1/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Gastrointestinal disorders
Cheilitis
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
20.0%
2/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
20.0%
4/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
32.3%
10/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
13.3%
4/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
42.9%
12/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
14.3%
26/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
9.1%
15/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Gastrointestinal disorders
Diarrhoea
|
70.0%
7/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
20.0%
2/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
35.0%
7/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
25.8%
8/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
13.3%
4/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.7%
3/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
28.6%
8/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
15.4%
28/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
9.7%
16/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
5.0%
1/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
6.5%
2/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
6.7%
2/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
4.9%
9/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.0%
5/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
5.0%
1/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.2%
1/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
6.7%
2/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
7.1%
2/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
2.7%
5/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
2.4%
4/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Gastrointestinal disorders
Nausea
|
30.0%
3/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
30.0%
3/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
30.0%
6/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
41.9%
13/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
26.7%
8/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
53.6%
15/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
25.0%
7/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
14.8%
27/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
13.3%
22/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
5.0%
1/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.3%
1/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
7.1%
2/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
1.1%
2/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
6/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
9.7%
3/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
2.2%
4/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
2.4%
4/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Gastrointestinal disorders
Vomiting
|
40.0%
4/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
20.0%
2/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
20.0%
4/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
19.4%
6/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
3/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
25.0%
7/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.7%
3/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
8.2%
15/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
6.7%
11/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
General disorders
Asthenia
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
2/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.2%
1/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.3%
1/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.7%
3/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
7.7%
14/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
5.5%
9/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
General disorders
Chest discomfort
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
1.1%
2/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
General disorders
Chills
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
5.0%
1/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
6.5%
2/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
6.7%
2/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
7.1%
2/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
1.6%
3/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
1.2%
2/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
General disorders
Face oedema
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.55%
1/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
General disorders
Fatigue
|
80.0%
8/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
50.0%
5/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
70.0%
14/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
80.6%
25/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
53.3%
16/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
71.4%
20/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
64.3%
18/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
37.9%
69/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
27.3%
45/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
General disorders
Gait disturbance
|
30.0%
3/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
20.0%
2/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
30.0%
6/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
16.1%
5/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
3/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
7.1%
2/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
8.8%
16/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
4.2%
7/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
General disorders
Influenza like illness
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
7.1%
2/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
7.1%
2/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
1.1%
2/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.0%
5/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
General disorders
Mucosal inflammation
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.2%
1/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
7.1%
2/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
1.1%
2/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
1.2%
2/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.2%
1/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.3%
1/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.7%
3/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.55%
1/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
2.4%
4/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
General disorders
Oedema
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
5.0%
1/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
1.2%
2/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
General disorders
Oedema peripheral
|
20.0%
2/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
2/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
12.9%
4/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
6.7%
2/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
7.1%
2/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
8.8%
16/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
9.1%
15/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
General disorders
Pain
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
5.0%
1/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.2%
1/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
17.9%
5/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
7.1%
2/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
2.2%
4/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.0%
5/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
General disorders
Pyrexia
|
20.0%
2/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
2/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
9.7%
3/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
3/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.7%
3/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
21.4%
6/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
7.1%
13/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
4.8%
8/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Infections and infestations
Candida infection
|
20.0%
2/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
2/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.2%
1/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
3/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
7.1%
2/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.7%
3/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.55%
1/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
2.4%
4/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Infections and infestations
Conjunctivitis
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.61%
1/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Infections and infestations
Enterocolitis infectious
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
5.0%
1/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
5.0%
1/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
6.5%
2/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.3%
1/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.55%
1/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
6.7%
2/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.3%
6/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
6/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Infections and infestations
Hordeolum
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
6.5%
2/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Infections and infestations
Klebsiella infection
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Infections and infestations
Mucosal infection
|
20.0%
2/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.8%
7/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
6/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Infections and infestations
Oral candidiasis
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
5.0%
1/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.2%
1/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.3%
1/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.7%
3/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
1.6%
3/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
1.2%
2/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Infections and infestations
Pneumonia
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
5.0%
1/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.2%
1/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
2.7%
5/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
1.2%
2/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Infections and infestations
Rash pustular
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.2%
1/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.55%
1/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Infections and infestations
Sinusitis
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.2%
1/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.3%
1/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
1.6%
3/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
1.2%
2/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Infections and infestations
Staphylococcal infection
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.55%
1/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Infections and infestations
Tooth infection
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
2/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.2%
1/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
1.2%
2/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Infections and infestations
Upper respiratory tract infection
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
2/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
12.9%
4/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.3%
1/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.3%
6/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
6/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
25.0%
5/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.2%
1/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
6.7%
2/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
7.1%
2/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
6.0%
11/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
4.2%
7/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Infections and infestations
Viral infection
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.55%
1/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
1.8%
3/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
6.5%
2/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
7.1%
2/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
2.2%
4/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.61%
1/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Injury, poisoning and procedural complications
Fall
|
30.0%
3/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
25.0%
5/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
9.7%
3/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
3/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
7.1%
2/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
9.9%
18/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
6.1%
10/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
7.1%
2/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
1.6%
3/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.61%
1/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Injury, poisoning and procedural complications
Radiation skin injury
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.2%
1/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.3%
1/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
7.1%
2/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Injury, poisoning and procedural complications
Vaccination complication
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Investigations
Alanine aminotransferase increased
|
40.0%
4/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
15.0%
3/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
29.0%
9/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
16.7%
5/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
17.9%
5/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
7.1%
2/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
8.8%
16/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
6.1%
10/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Investigations
Amylase increased
|
30.0%
3/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
5.0%
1/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
12.9%
4/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
6.7%
2/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
7.1%
2/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
7.1%
2/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
2.2%
4/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
1.8%
3/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Investigations
Aspartate aminotransferase increased
|
40.0%
4/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
2/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
29.0%
9/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
3/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
14.3%
4/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
7.1%
2/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.3%
6/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
1.8%
3/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Investigations
Blood alkaline phosphatase increased
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
5.0%
1/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.2%
1/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.3%
1/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
7.1%
2/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
2.7%
5/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
5.0%
1/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
6.5%
2/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
6.7%
2/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
1.6%
3/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.61%
1/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Investigations
Blood creatinine increased
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
6.7%
2/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.7%
3/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
1.6%
3/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
1.2%
2/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
1.6%
3/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
1.2%
2/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Investigations
Lipase increased
|
40.0%
4/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
20.0%
2/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
2/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
19.4%
6/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
16.7%
5/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
7.1%
2/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
5.5%
10/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.0%
5/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
15.0%
3/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
19.4%
6/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
3/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.7%
3/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
7.1%
2/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
1.1%
2/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.0%
5/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
16.1%
5/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.61%
1/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Investigations
Platelet count decreased
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
15.0%
3/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
25.8%
8/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
6.7%
2/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
17.9%
5/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
7.1%
2/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.8%
7/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.0%
5/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Investigations
Weight decreased
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
5.0%
1/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
12.9%
4/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
3/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.7%
3/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
2.7%
5/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
4.2%
7/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Investigations
Weight increased
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
5.0%
1/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
6.7%
2/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
2.7%
5/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
2.4%
4/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Investigations
White blood cell count decreased
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
5.0%
1/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
19.4%
6/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.3%
1/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
7.1%
2/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
1.1%
2/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
1.8%
3/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Investigations
White blood cell count increased
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
7.1%
2/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Metabolism and nutrition disorders
Decreased appetite
|
20.0%
2/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
15.0%
3/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
16.1%
5/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
3/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
25.0%
7/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
32.1%
9/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
6.0%
11/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
5.5%
9/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Metabolism and nutrition disorders
Dehydration
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
2/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
9.7%
3/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.3%
1/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
14.3%
4/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
1.6%
3/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.61%
1/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
30.0%
3/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
25.0%
5/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
22.6%
7/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
23.3%
7/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
21.4%
6/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
7.1%
2/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
5.5%
10/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
2.4%
4/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
6.5%
2/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
1.1%
2/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
1.2%
2/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Metabolism and nutrition disorders
Hyperlipasaemia
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
6.5%
2/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.61%
1/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
2/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
6.5%
2/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
1.1%
2/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
5.0%
1/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
9.7%
3/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.3%
1/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.55%
1/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.61%
1/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
2/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
12.9%
4/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
6.7%
2/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
7.1%
2/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
7.1%
2/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
2.7%
5/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
6/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
6.5%
2/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
1.1%
2/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.61%
1/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
2/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
16.1%
5/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
16.7%
5/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
7.1%
2/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
7.1%
2/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
2.2%
4/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.61%
1/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
15.0%
3/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
29.0%
9/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
13.3%
4/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
25.0%
7/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
14.3%
4/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
14.3%
26/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
13.3%
22/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
20.0%
2/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
5.0%
1/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
19.4%
6/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
6.7%
2/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
17.9%
5/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
7.1%
13/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
6.7%
11/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
6.5%
2/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.2%
1/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.3%
1/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
5.5%
10/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.0%
5/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
20.0%
2/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
30.0%
3/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
25.0%
5/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
9.7%
3/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
6.7%
2/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.7%
3/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.7%
3/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
8.2%
15/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
9.1%
15/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
20.0%
2/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
5.0%
1/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
9.7%
3/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.3%
1/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.7%
3/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.8%
7/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
6.1%
10/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.2%
1/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
3/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
8.2%
15/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
5.5%
9/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.2%
1/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Nervous system disorders
Amnesia
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
5.0%
1/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
6.5%
2/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.3%
1/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
2.2%
4/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
1.8%
3/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Nervous system disorders
Aphasia
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
2/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
19.4%
6/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
3/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
17.9%
5/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.7%
3/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
15.4%
28/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
12.7%
21/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Nervous system disorders
Ataxia
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
5.0%
1/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.2%
1/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
2.7%
5/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
1.2%
2/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
5.0%
1/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.7%
3/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.8%
7/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Nervous system disorders
Brain oedema
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
5.0%
1/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
7.1%
2/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
4.4%
8/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Nervous system disorders
Cognitive disorder
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
15.0%
3/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
16.1%
5/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
6.7%
2/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.7%
3/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
5.5%
10/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
6/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.7%
3/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
7.1%
2/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
4.9%
9/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
1.2%
2/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Nervous system disorders
Dizziness
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
40.0%
4/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
20.0%
4/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
25.8%
8/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
16.7%
5/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
7.1%
2/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.7%
3/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
8.8%
16/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
6.7%
11/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Nervous system disorders
Dysarthria
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
20.0%
2/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
2/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
6.5%
2/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.3%
1/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
14.3%
4/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
2.7%
5/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.0%
5/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
6.5%
2/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
6.7%
2/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
7.1%
2/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.55%
1/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Nervous system disorders
Dyspraxia
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Nervous system disorders
Facial paresis
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
2/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
6.5%
2/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.3%
1/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.55%
1/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
1.2%
2/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Nervous system disorders
Haemorrhage intracranial
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
5.0%
1/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.55%
1/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.61%
1/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Nervous system disorders
Headache
|
70.0%
7/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
70.0%
7/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
50.0%
10/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
45.2%
14/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
43.3%
13/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
60.7%
17/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
39.3%
11/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
31.3%
57/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
32.1%
53/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Nervous system disorders
Hemiparesis
|
30.0%
3/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
30.0%
3/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
35.0%
7/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
16.1%
5/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
6.7%
2/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
14.3%
4/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.7%
3/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
14.8%
27/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
9.7%
16/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
6.5%
2/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
16.7%
5/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
2.7%
5/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.0%
5/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Nervous system disorders
Lethargy
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
20.0%
4/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.2%
1/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.55%
1/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.61%
1/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Nervous system disorders
Memory impairment
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
30.0%
3/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
20.0%
4/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
6.5%
2/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
3/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
7.7%
14/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
6.1%
10/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
2/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
9.7%
3/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.3%
1/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.7%
3/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
7.1%
2/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
4.9%
9/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.0%
5/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Nervous system disorders
Partial seizures
|
30.0%
3/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.2%
1/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.3%
1/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
2.7%
5/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
2.4%
4/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
6.7%
2/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
1.6%
3/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.61%
1/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Nervous system disorders
Presyncope
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
1.1%
2/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.61%
1/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Nervous system disorders
Psychomotor skills impaired
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
2/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
1.1%
2/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
1.2%
2/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Nervous system disorders
Seizure
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
20.0%
2/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
2/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
9.7%
3/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
23.3%
7/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
21.4%
6/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
42.9%
12/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
18.1%
33/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.3%
17/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Nervous system disorders
Syncope
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
9.7%
3/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.55%
1/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.61%
1/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Nervous system disorders
Tremor
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
5.0%
1/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
6.5%
2/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
3/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
7.1%
2/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
2.2%
4/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
2.4%
4/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Nervous system disorders
Vasogenic cerebral oedema
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
5.0%
1/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Psychiatric disorders
Agitation
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
2/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.2%
1/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
2.7%
5/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
2/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
12.9%
4/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
16.7%
5/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
14.3%
4/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.3%
6/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
6/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Psychiatric disorders
Confusional state
|
30.0%
3/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
30.0%
3/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
45.0%
9/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
6.5%
2/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
3/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
21.4%
6/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.7%
3/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
8.2%
15/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
6.1%
10/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Psychiatric disorders
Delusion
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Psychiatric disorders
Depression
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
5.0%
1/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.2%
1/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
3/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
21.4%
6/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.3%
6/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
6.1%
10/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
2/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
1.1%
2/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
1.8%
3/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Psychiatric disorders
Hallucination
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.55%
1/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Psychiatric disorders
Insomnia
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
5.0%
1/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
6.5%
2/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
16.7%
5/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
21.4%
6/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.7%
3/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
8.8%
16/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
9.1%
15/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Psychiatric disorders
Irritability
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.2%
1/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.3%
1/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
1.1%
2/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
1.2%
2/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
6.7%
2/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.55%
1/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
5.0%
1/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
6.5%
2/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.61%
1/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
5.0%
1/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.2%
1/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
7.1%
2/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
1.1%
2/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
1.8%
3/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
5.0%
1/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
7.3%
12/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Renal and urinary disorders
Urinary hesitation
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.55%
1/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Renal and urinary disorders
Urinary incontinence
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
20.0%
4/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.2%
1/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
3/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
4.4%
8/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
1.2%
2/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Renal and urinary disorders
Urinary retention
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
1.1%
2/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.61%
1/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.2%
1/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.55%
1/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.61%
1/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
30.0%
3/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
45.0%
9/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
16.1%
5/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
16.7%
5/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.7%
3/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
17.9%
5/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
12.6%
23/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
7.3%
12/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
20.0%
2/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
5.0%
1/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
1.1%
2/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
6.1%
10/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
2/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
9.7%
3/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.3%
1/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
7.1%
2/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
2.7%
5/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
5.5%
9/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.55%
1/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
1.2%
2/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
1.1%
2/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
6.1%
10/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
20.0%
4/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
12.9%
4/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
6.7%
2/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
7.1%
2/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.7%
3/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.8%
7/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
1.8%
3/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
9.7%
3/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.7%
3/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.8%
7/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
4.2%
7/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
5.0%
1/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.2%
1/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.3%
1/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
1.6%
3/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
1.2%
2/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar erythema
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.2%
1/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
7.1%
2/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
2.7%
5/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
2.4%
4/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
19.4%
6/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
6.7%
2/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
14.3%
4/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
17.9%
5/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.55%
1/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.61%
1/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
1.1%
2/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.61%
1/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
5.0%
1/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
6.5%
2/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.3%
1/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
1.6%
3/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.61%
1/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
7.1%
2/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
30.0%
3/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
5.0%
1/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
25.8%
8/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.3%
1/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.7%
3/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
7.1%
13/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
1.2%
2/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Skin and subcutaneous tissue disorders
Erythema
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
2.2%
4/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
2.4%
4/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
20.0%
2/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
30.0%
6/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
22.6%
7/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
3/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
7.1%
2/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
14.3%
4/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
11.0%
20/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
4.2%
7/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
20.0%
2/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
25.0%
5/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
25.8%
8/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
6.7%
2/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
7.1%
2/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
32.1%
9/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
9.9%
18/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
4.8%
8/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
40.0%
4/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
2/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
16.1%
5/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
13.3%
4/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.8%
7/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
1.8%
3/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
5.0%
1/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.2%
1/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.3%
1/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
7.1%
2/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
1.1%
2/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
1.2%
2/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Vascular disorders
Hypertension
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
5.0%
1/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
16.1%
5/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
20.0%
6/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
10.7%
3/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
6.6%
12/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
30.3%
50/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Vascular disorders
Hypotension
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
5.0%
1/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.2%
1/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.3%
1/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
3.6%
1/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
7.1%
2/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
1.6%
3/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
1.2%
2/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
|
Vascular disorders
Pelvic venous thrombosis
|
10.0%
1/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/10 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/20 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/31 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/30 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/28 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/182 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
0.00%
0/165 • All-Cause Mortality: From randomization (cohorts 1, 2, and 1c/1d of Part B) or first dose (cohorts 1b, and 1c/1d of Part A) through the course of the trial (up to approximately 125 months). SAEs and NSAEs: From first dose (SAEs and NSAEs) to 100 days post last dose (up to approximately 113 months). SAEs = Serious Adverse Events NSAEs = Non-Serious Adverse Events ("Other Adverse Events", as labeled in the table below)
All-Cause Mortality = randomized (cohorts 1, 2, and 1c/1d of Part B) and treated (cohorts 1b, and 1c/1d of Part A) participant populations. SAEs and NSAEs (Other Adverse Events) = treated participant population
|
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